Professional Documents
Culture Documents
Version 4
For PASCAL® Dynamic Contour Tonometers
September 2012
311.951.101
Doc # 6100-50-0005-04
Caution: Federal (U.S.) Law restricts this device to sale by or on the order of a physician.
Manufactured by:
SMT Swiss Microtechnology AG
a Ziemer Group Company
Allmendstrasse 11
CH-2562 Port, Switzerland
Phone: +41 32 332 7080
e-mail: vision@smtag.ch
web: www.pascal-tonometer.com 0297
TABLE OF CONTENTS
1. INTRODUCTION .................................................... 4 6.2.3. Manometer Mode ................................................... 33
6.2.4. Calibration of Main Unit and SensorTips ................ 33
1.1. PASCAL® Systems covered in this Manual ......... 4
1.2. Indications for use ............................................... 4 6.3. Cleaning ............................................................ 33
1.3. General description ............................................. 4 6.4. Maintenance and repairs ................................... 34
1.4. How to use this manual ....................................... 5 6.5. Disposal ............................................................ 34
1.4.1. Explanation of symbols ............................................. 6 7. TROUBLESHOOTING ......................................... 35
2. SYSTEM COMPONENTS ...................................... 7 7.1. Troubleshooting guide ....................................... 35
2.1. Main Unit ............................................................. 7 7.2. Error Messages and Status Messages.............. 37
7.2.1. PASCAL Main Unit ................................................. 37
2.2. PASCAL Firmware .............................................. 7
7.2.2. Printer status messages (on PASCAL Main Unit): . 38
2.3. Accessories and Consumables ........................... 8
7.2.3. PC status messages (on PASCAL Main Unit): ....... 38
2.3.1. PASCAL Wireless Printer ......................................... 8
7.2.4. Printer status messages (on printer): ..................... 39
2.3.2. Adapter Kit for Haag-Streit-type Slit Lamps .............. 8
7.2.5. PC status messages (from USB Adapter): ............. 40
2.3.3. Swing Arms for various types of slit lamps ............... 8
2.3.4. Test Kit ...................................................................... 8
7.3. Frequently asked questions .............................. 41
2.3.5. Additional SENSORTIPS ............................................. 8 7.4. Tips and Tricks ................................................ 43
2.3.6. SENSORCAP™ Disposable Tip Covers ...................... 9 7.4.1. Optimizing patient cooperation ............................... 43
2.3.7. Non-rechargeable Battery Packs .............................. 9 7.4.2. Working with SENSORCAP protective tip covers ...... 43
2.3.8. Rechargeable Battery Packs .................................... 9 7.4.3. Working with SensorTips ........................................ 43
7.4.4. Working with the wireless printer ......................... 43
2.4. Additional required material (not supplied) .......... 9
3. SAFETY INSTRUCTIONS.................................... 10 8. APPENDIX ........................................................... 44
3.1. Intended Use ..................................................... 10 8.1. Dynamic Contour Tonometry ............................ 44
8.1.1. Functioning principle of Contour Tonometry .......... 44
3.2. Patient Safety .................................................... 10
8.1.2. Comparing with applanation tonometry data .......... 44
3.3. Operational Safety............................................. 10 8.1.3. "Unexpectedly different" results.............................. 45
4. PROCEDURES .................................................... 12 8.1.4. Dealing with lacrimation.......................................... 46
4.1. System set-up ................................................... 12 8.1.5. Dynamic Tonometry vs. Static Tonometry ............. 47
4.1.1. Attaching PASCAL to your slit lamp ....................... 12 8.2. How does PASCAL compute IOP and OPA? .... 48
4.1.2. Readying PASCAL for taking measurements ....... 13 8.2.1. The Q score ............................................................ 49
4.2. Disposables and consumables .......................... 14 8.3. PASCAL Firmware Structure ............................. 50
4.2.1. Fitting a SENSORCAP ............................................. 14 8.4. Technical Specifications .................................... 51
4.2.2. Replacing the Battery.............................................. 15 8.4.1. Tonometer System ................................................. 51
4.2.3. Replacing the SENSORTIP ....................................... 15 8.4.2. Printer Accessory ................................................... 51
4.3. Preparations for taking measurements............ 16 8.4.3. Rechargeable Battery Kit........................................ 52
4.4. Taking measurements ..................................... 17 8.4.4. System Components .............................................. 53
8.4.5. Manufacturer’s EMC Declaration............................ 54
5. PASCAL OPERATING INSTRUCTIONS ............. 20
8.5. Accessories and Consumables ......................... 60
5.1. Basic Procedures .............................................. 20
8.6. Warranty Information ......................................... 60
5.1.1. The BLUE KNOB ....................................................... 20
5.1.2. The Interrupt Maneuver .......................................... 21 8.7. Service and Support Information ....................... 61
5.2. Other operations................................................ 22
5.2.1. Adjusting PASCAL user settings ............................ 22
5.2.2. The Prior Results List.............................................. 25
5.3. Wireless Communication with a Printer or PC ... 25
5.3.1. Getting started with the Printer ............................... 25
5.3.2. Initializing the Printer .............................................. 25
5.3.3. Setting Print Parameters ......................................... 25
5.3.4. Printing .................................................................... 26
5.3.5. Initializing the PC .................................................... 26
5.3.6. PC Transfer............................................................. 26
5.4. Reference information ....................................... 27
5.4.1. BLUE KNOB Actions ................................................. 27
5.4.2. User Settings Menu ................................................ 28
5.4.3. Printer Reference Information ................................. 28
5.4.4. Battery Charger Reference Information .................. 29
6. CARE AND MAINTENANCE ............................... 30
6.1. Periodic check of SENSORTIP ............................. 30
6.1.1. Visual Inspection of SensorTips ............................. 30
6.1.2. Appearance of Pressure Curves ............................. 31
6.1.3. Recommendations to avoid degradation ................ 31
6.2. System checks and calibrations ........................ 32
6.2.1. Performance Test ................................................... 32
6.2.2. Cantilever Test ........................................................ 33
List of Figures
Fig. 1 Typical pressure curve, recorded for approx. 7 seconds.
Several ocular pressure pulsations are recorded, from
which PASCAL software computes IOP (referenced to
zero pressure as detected after the Interrupt), and OPA. 4
Fig. 2 PASCAL Main Unit components 7
Fig. 3 PASCAL mounted on short swing arm bracket 12
Fig. 4 Mounting Bracket with S1 guides 12
Fig. 5 Mounting Bracket with S2 guides 12
Fig. 6 PASCAL mounted on slit lamp 12
Fig. 7 Main Unit with attached Mounting Plate being inserted on
slit lamp central axis. 13
Fig. 8 PASCAL mounted on slit lamp axis by means of
Mounting Plate. 13
Fig. 9 SENSORTIP with applied SENSORCAP (correct fit):
membrane of Cap follows curved tip surface smoothly; no
folds or air pockets can be seen. 14
Fig. 10 SENSORTIP with applied SENSORCAP (incorrect fit):
membrane of Cap does not adhere to tip surface;
stretching folds can be seen. 14
Fig. 11 SENSORTIP with applied SENSORCAP (incorrect fit):
membrane of Cap does not adhere to tip surface; air
bubble fills entire space between tip and membrane. 14
Fig. 12 Motion of PASCAL CANTILEVER and SENSORTIP: 17
Fig. 13 View of Contact Zone and pressure sensor through slit
lamp microscope. 18
Fig. 14 Contact Zone misaligned. 18
Fig. 15 LCD display of an exam result after completion of
measurement (example): IOP Intra-ocular Pressure
19.4 mmHg OPA Ocular Pulse Amplitude 3.2 mmHg Q
Quality score 1 (best), 2 and 3 (acceptable), 4 and 5
(discard measurement and repeat) 18
Fig. 16: FW 4.01 Menu structure 24
Fig. 17 Display of an exam result in Results List (example): #
Exam number (12345) P intra-ocular pressure (IOP) 12.5
mmHg Q Quality score 1 (best) H Heart rate 75 beats/min
A Ocular Pulse Amplitude (OPA) 2.1 mmHg 25
Fig. 18 Performance Test Kit 32
Fig. 19 Contour Tonometer. Schematic representation of
cylindrical, contoured tip in contact with cornea (“Contour
Match”). 44
Fig. 20: excessive lacrimation: entire lens filled with tear fluid. 47
Fig. 21 regular pattern: contact area is circular and smaller than
total lens diameter. 47
Fig. 22 poor lacrimation; tear-film breaks up from top. 47
Fig. 23 PASCAL Firmware Structure: Recording Mode and
Settings Mode 50
1. Introduction
1.1. PASCAL® Systems covered in this Manual
This manual covers two versions of the PASCAL® Dynamic Contour Tonometer:
1. The standard PASCAL® System
311.001.001 has an S1-type mounting bracket
311.001.002 has an S2-type mounting bracket
2. The PASCAL® WIRELESS System; enabled for wireless communication with printers and computers
311.011.001 has an S1-type mounting bracket
311.011.002 has an S2-type mounting bracket
Most of the information provided applies equally to both types of PASCAL system.
Additional functionalities available only with PASCAL WIRELESS systems are marked with this symbol:
"systolic IO P" O PA
Section 2 System Components provides an overview of the major components of the PASCAL Tonometer
(page 7) System, with illustrations showing all system components.
Section 3 Safety Instructions specifies the intended use of the PASCAL Tonometer and provides
(page 10) important guidelines for patient safety and operational safety. Please study this section carefully.
Section 4 Procedures provides step-by-step instructions on setting up and using the PASCAL device.
(page 12)
Section 5 PASCAL Operating Instructions contains systematic reference information on all procedures
(page 20) (IOP measurement, instrument settings, etc…).
Section 6 Care and Maintenance contains information on how to perform system checks and calibrations,
(page 29) on cleaning the device, and on maintenance and repairs.
Section 7 Troubleshooting contains a troubleshooting guide, a complete listing of error messages and
(page 35) status messages, and a “Frequently asked Questions” section.
Section 8 The Appendix contains background information on Dynamic Contour Tonometry, on system
(page 44) software, and on technical specifications.
1.4.1. Explanatio
on of symbo
ols
Caution Typ
pe BF appliedd part.
Electronic com
mponents subject to the European U Union
Directive 2002
2/96/EC on Waste e Electrical and Eleectronic
Equipment. Components marke ed with this symbool must be cycle after usse.
Rec
arately and recycle
collected sepa ed. For details seee section
8.4.4
2. System Components
2.1. Main Unit
The PASCAL system is contained in a single, slit lamp-mounted housing (the Main Unit), and includes
several single-use and multi-use components that are attached by the user to the Main Unit.
The Main Unit contains the system’s electronics and mechanics. It features a Liquid Crystal Display (LCD), a
Control Switch (“BLUE KNOB”), and the integrated CANTILEVER, which in turn supports the Tip Carrier. The
CANTILEVER is a spring-loaded arm which applies the SENSORTIP™ to the patient’s eye with a constant,
defined appositional force of approximately 1 gram throughout its range of motion. An integrated micro-
processor controls all system functions and performs the computation of results from recorded data.
Fig. 2 PASCAL Main Unit components
SENSORTIP™ (removable)
TIP CARRIER
CANTILEVER
MOUNTING BRACKET
Battery Pack
BASE PLATE
(part of optional Adapter Kit)
For a complete working arrangement, the Main Unit is mounted on your slit lamp using either the FOOTPLATE
and BASE PLATE (packaged together as the optional ADAPTER KIT), or a swing arm, depending on the type
and manufacturer of your slit lamp. Furthermore, a Battery Pack must be inserted into the Main Unit and a
SENSORTIP must be inserted into the Tip Carrier.
SENSORCAP™ Disposable Tip Covers are placed over the SENSORTIP in order to prevent contamination and
infection, and to protect the pressure sensor from the corrosive effects of the patient’s tear film. The
APPLIPACK sterile packaging of each SENSORCAP serves as an applicator for easy fitting of the SENSORCAP
over the SENSORTIP.
An optional Test Kit is available for users who wish to periodically check calibration of the PASCAL pressure
sensor.
FOOTPLATE B (311.640.008) suits all Haag-Streit BC slit lamps, which have a central axis without locking
device (like Zeiss models 120 – 130 – 160 → recent models). Support disks will be provided together with
FOOTPLATE B.
Slit lamps, which do not have a central axis with locking device (where FOOTPLATE A would freely rotate),
FOOTPLATE B is the solution. The peg with the slit of FOOTPLATE B can be spread-out with the supplied screw
to prevent any rotation. The supplied support disks help to adjust the height, so that the PASCAL SensorTip
is aligned with the optical axis of the slit lamp. Caution: Please do not strip the screw; just turn it to the point
where the FOOTPLATE B is held slightly, otherwise the thread may be damaged.
For Zeiss SL125 slit lamps replace Zeiss screw-on plate with modified plate from SMT; install using
FOOTPLATE B (311.640.008) and Base plate (311.640.006).
3. Safety Instructions
3.1. Intended Use
PASCAL is a Class IIa medical device, intended for in-office use by ophthalmologists (and in the USA and
UK, by optometrists).
Caution and professional judgment should be used when attempting to use PASCAL on patients with
eye diseases; particularly in cases of exterior eye infections, epithelium damage or corneal damage
or pathology.
To avoid infection or contamination, PASCAL must be used only with a SENSORCAP Disposable Tip
Cover applied over the SENSORTIP. For each patient, a fresh SENSORCAP taken from the sterile
AppliPack must be used. Note that besides putting patients at risk, using the device without a
SENSORCAP may also cause damage to the SENSORTIP and may give rise to measurement errors.
Before each use, check the SENSORTIP carefully for any damage to its surface which might expose
the patient to a risk of local corneal abrasion.
Do not advance PASCAL towards patient beyond the maximum excursion range of the CANTILEVER.
If the alarm sounds (repeated beeping), retract immediately.
Avoid contact of Main Unit with any liquids other than moderate amounts of alcohol (ethyl or
isopropyl alcohol) used for cleaning.
The SENSORTIP may be cleaned cautiously, using water with a few drops of liquid soap added, if it
has been inadvertently contaminated. Repetitive, frequent cleaning may damage the tip. Therefore,
do not use the SENSORTIP without the protection provided by a SENSORCAP tip cover.
Periodically check the SENSORTIP according to chapter 6.1 for any damage. The functioning of
SensorTips may be compromised by improper cleaning, by mechanical wear and tear, or by storing
the SensorTip with a SensorCap mounted for prolonged periods of time.
Do not touch the contour surface of SENSORTIP, or any other system components, with any hard
objects, abrasive cleaning agents, or any cloth or paper towels containing hard fibers. SENSORTIPs
that are not being used should always be stored in their container to prevent damage to the contact
surface or to the electrical contacts.
Activate the BLUE KNOB with a gentle twist (approx. 10° rotation only). Parts may break if excessive
force is used.
Handle CANTILEVER gently. Excessive force acting on it may cause improper functioning and may
generate erroneous IOP results.
Disposable Battery Packs are not rechargeable. Use only original PASCAL Battery Packs supplied
by SMT or accredited dealers.
Do not open the Main Unit. Attempting to do so will void the Warranty.
Only accessories, parts and consumables supplied by SMT should be used. Use of third-party items
may pose a safety hazard and may void the warranty.
(Applies to PASCAL WIRELESS systems only:) Changes or modifications not expressly approved by
the manufacturer could void the user's authority to operate the equipment.
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the
FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is
operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instruction manual, may cause harmful interference to radio communications.
Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required
to correct the interference at his own expense.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may
not cause harmful interference, and (2) this device must accept any interference received, including interference that may
cause undesired operation.
4. Procedures
Some of thhe procedures described d in this sec
ction (marke
ed with a symbol) are
a available as
video sequuences on DVD.
D For gaaining a betteer understannding, it is rrecommende ed to follow the
appropriate
e sections of the instructio
on video while studying the
t user mannual.
The screws used for the Go oldmann tonommeter are too lon
ng and should no
ot
be used for attaching the PASCAL
P to the ttonometer brack
ket.
b) Somme slit lampss have a Goldmann ton nometer attaached by means of a llong
swinng arm bra acket which slides onto o the acces ssory mountt on top off the
micrroscope and is screwed into i the base
e of the Golddmann Tonometer. To atttach
the PASCAL in lieu of the Goldmann, the BASE PLATE (Ref. 311.640.0066) is
requuired. Unscre ew the Gold dmann and keep the sc crew. Screww the PASCACAL’s
BASE E PLATE ontoo the swing arm
a using th e alignment pin and the hole provideed in
the BASE PLATE. Mount the PASCAL o onto the Basse plate by aligning the two
holes found in th he bottom off the PASCA AL Main Unitt with the tw
wo corresponnding
pegss protruding from the BAS SE PLATE. Ins p (311.640.103) and sliide it
sert the key pin
overr to firmly lo
ock the PAS SCAL to the BASE PLATE. Re-attach h the swing arm
braccket to the slit lamp. (Fig. 6)
Fig. 6 PASCAL moun
nted on slit lampp
c) Usin
ng the optional Adapter Kit (311.64 40.005), the Main Unit may be direectly
mouunted on the central axis of most slit la amp types. Mount
M the PA ASCAL onto the BASE PLATEL by align
ning
the ttwo holes fou und in the boottom of the PASCAL Ma ain Unit with the two corrresponding pegs
p protrud
ding
m the BASE PLATE. Insert the key pin ((311.640.103
from 3) and slide it over to firmmly lock the PASCAL to the
BASE E PLATE. Scrrew the FOO OTPLATE onto o the BASE PLATE by mea ed. Then fit the
ans of the sscrew provide
peg of the FOOTP PLATE A into the hole in t he slit lamp axis and turn n until the FO
OOTPLATE A drops
d into pla
ace
on th
he alignmentt bar (Fig. 7;; Fig. 8).
d) Special Configu urations: So ome types off slit lamps require
r a diffferent kind of BASE PLATE, or a differrent
FOOTPLATE. For some types of slit lampss, suitable sw wing arm brackets are alsso available. Please conttact
yourr distributor fo
or details on available sp
pecial adapte er kits.
Fig. 7 M
Main Unit with attached Mountin
ng Plate being iinserted on Fig. 8 PASCA
AL mounted on slit lamp axis by means of
sslit lamp centrall axis. Mounting Plate.
FOOTPLAATE
Slit lamp
p axis
T
To store your PASCAL Main UnitU in its carryin ng case, you will
w need to remo
ove the FOOTPLLATE. Carefully store Plate and
d
a
attachment screw in the carrying case for future
re use.
4.2. Disposab
bles and consumab
c bles
OK
Never use the same SENSORCAP o on more thaan one patient. Attemptinng to wipe the
t SENSORCAP
may damagge it and may
y cause instrrument malfu
unction.
1 Before SEN
NSORTIP touches s eye, or if patieent moves away
y from the slit
3
lamp, CANT
TILEVER (red) tilts forward.
10) Obse erve the area where the SENSORTIP ttouches the patient’s corrnea. This “C Contact Zone e” will appearr as
a da arker area tha
at becomes circular wheen the SENSO ORTIP is prop e joystick on the
perly centereed. Using the
slit lamp, adjust the position
n of the SENNSORTIP sligh htly until the opaque spoot enclosing the blue-gre een
squa are of the pre
essure senso
or is concenttric with the Contact
C Zonee.
Fig. 13
3 View of Conta
act Zone and pressure sensor tthrough slit lamp microscope.
Thee opaque spot in he pressure sennsor obstructing the view of the
n the center is th e
eye . Notice that forr proper alignmeent the pressuree sensor should be centered onn
the Contact Zone, and a not necessa arily centered oon the pupil.
e circular Contac
The ct Zone is darkeer than the surroounding area, with
w the tear film
der clearly visible. Contact Zone should be cenntered around sensor
bord s (in this
phottograph, sensorr appears very slightly
s displaceed towards nine o'clock, but
centtration is sufficie
ent for obtaining
g a good, valid ppressure reading).
Fig. 14
4 Contact Zone misaligned.
his view, SensorTip is placed to
In th oo high on the eeye. Move slit la
amp down to brin
ng
Con ntact Zone into proper
p alignmennt.
In a situation as shown, the sensor will not detect any pressure, and
a no audio
feeddback sound willl be heard. As soon
s as the sennsor moves into the center of th
he
Conntact Zone, the sound
s will be he
eard and a reguular measurement can be taken n.
11) Liste
en for a regular continuoous oscillatin
ng sound, which
w is generated by thhe pulsating IOP when the
SENS SORTIP has established
e correct contaact and align
nment with the t cornea. C Count approoximately five e to
seveen consecutivve undisturbed waveform ms. If during measurement the CANTILLEVER is not deflected aw way
m its forward position eno
from ough, the osscillating sou
und will be in ntermittent aand irregularr. If this occu
urs,
pushh the joysticck towards the
t patient, at which time the intermittent osccillating soun nd will beco ome
conttinuous. If th
he CANTILEVE
ER is deflecte
ed back too faar, an alert (persistent reepetitive beep
ps) will soundd.
If the Cantilever alert (persistent
( re
epetitive bee
eps) sounds during
d meassurement, pull the PASCA AL
and slit lam
mp away from the patien nt’s eye. Adv
vancing the device
d e patient while
furtheer towards the
the alert sounds mightt exert excesss force on thhe patient's eye,
e causing injury.
12) Afterr you have reached
r the desired Qua n be set by the Q indicaator accordin
ality (that can ng to Figure 16)
indiccated by the 3 tone melo ody, swiftly rretract the sllit lamp and the SENSOR om the patient’s
RT IP away fro
eye. When the pressure sensed by the e PASCAL dropsd to zero
o upon interrruption of contact
c with the
cornnea, the sounnd will vanish and a dou uble beep will confirm tha at the zero ppressure bas seline has be
een
deteected. This decoupling
d of
o the SENSSORTIP from the cornea will be refe ferred to as performing an
”Inte
errupt", or an
n "Interrupt Maneuver”.
M Itt is an importtant conceptt in taking vaalid IOP meaasurements with
w
PAS SCAL and willl be discusse ed in detail inn section 5.1
1.
13) The PASCAL will now compute IOP (Intrra-ocular Pre essure) and OPA (Ocularr Pulse Amp plitude) from the
presssure curve just recorded
d. The LCD w
will illuminate
e for 20 seco
onds and dissplay the res
sult for a tota
al of
60 seconds. (Figg. 15).
Fig. 15 LC
CD display of an exam result aafter completion of
measurement
m (example):
IO
OP Intra-ocular Pressure 199.4 mmHg
OPA
O Ocular Puulse Amplitude 3.2 mmHg
Q Quality sc
core 1 (best), 2 and 3 (accepta
able), 4
and
a 5 (discard measurement
m annd repeat)
In fact, the
e system will be ready fo
or the subseq
quent measurement as sooon as the re esult has bee
en
computed d and display
yed. As soon as this has happened, you y may initiaate the next measuremen nt;
but be aw ware that upo
on doing so thhe displayed
d result will disappear from
m the LCD.
Results remain stored in the device’s memory even after the display has disappeared. To re-
display results from previous measurements, refer to section 5.2.2.
15) Restart this procedure at step 8) oben for the next measurement.
Fig. 16. When a selected menu item is being displayed, its value may be adjusted within its defined limits by
repeated “short clicks”. Both menu selections and value settings will cycle; i.e. after the last value, the first
one will appear again.
a) Prior Results List: see next section.
b) Language: Messages and parameters displayed by the program are available in several languages.
Toggle to your preferred language with repeated “short clicks”; then proceed to next menu item with a
“long click”. Factory setting is “English”.
c) Volume: The loudness of the audio feedback may be adjusted from 0 (off) to 7 (loud) with repeated
“short clicks”. Factory setting is 4.
d) Contrast: The contrast of the LCD may be adjusted from 1 (low contrast) to 8 (maximum contrast).
Factory setting is 2.
e) System Info: The version number of the installed system software, the serial (S/N), part (P/N) and lot
(L/N) numbers of the Tonometer (T), Battery (B), and SensorTip (S) and the calibration value are
displayed in abbreviated form. (These values are for display only; they may not be adjusted by user).
f) Performance Test: (see section 6.2.1) A special operating mode for performing a functional test may be
activated with one short click. Displayed message will change from "disabled" to "active".
g) CANTILEVER Test: (see section 6.2.2) A special operating mode for checking proper mechanical
functioning of the CANTILEVER may be activated with one short click. Displayed message will change
from "disabled" to "active".
h) Manometer Mode: (see section 6.2.3) A special operating mode for checking proper functioning of the
pressure sensor may be activated with one short click. Displayed message will change from "disabled" to
"active".
i) Wireless Mode (see section 5.3): This item is only displayed on PASCAL WIRELESS systems that are
enabled for wireless communication. The currently active mode is displayed and will be performed after
every measurement. The mode may be changed by "short clicks" and letting PASCAL WIRELESS
system auto power-off.
j) Wireless Action (see section 5.3): This item is only displayed on PASCAL WIRELESS systems that are
enabled for wireless communication. One time wireless action will be started after a timeout of 5
seconds.
k) Changes in the settings are only becoming effective if the PASCAL system has properly turned itself off.
Note: Heart rate is a rough estimate for the patient's pulse rate, derived from just a few systoles and diastoles. The value provided by
the algorithm may not correspond to what is obtained using standard medical procedures.
"print values" will generate a basic printout which contains just numerical IOP, OPA, and Q values as
displayed on the PASCAL LCD.
"print val/range" will generate the same numerical values as above, plus a diagram showing a selected,
expanded section of the patient's IOP curve.
"print val/curve" is similar to "print val/range" above, but it will generate two curve views: one showing the
entire curve recorded, and the other the expanded curve.
To select the desired printout format, enter the PASCAL User Settings menu with a long click of the BLUE
KNOB, then toggle forward to "Wireless Mode" with repeated long clicks as described in Section 5.2.1. Then
select the desired option with repeated short clicks. Confirm your choice with a long click, then wait for your
PASCAL to power down.
5.3.4. Printing
When the printer has been initialized and appropriate print settings have been chosen, and if the printer is
turned on, the result will automatically print each time a measurement is completed. Every printout shows the
serial number of the PASCAL WIRELESS System and its SensorTip.
To suppress printing, deactivate printing in the Wireless Mode menu.
If an error condition is detected, the appropriate error message will be displayed on the PASCAL LCD.
Correct the error condition and perform a short click of the BLUE KNOB to acknowledge. If the result will still
not print after 3 attempts to correct the error condition, the message "Aborted. Note result" will appear, and
the result will be displayed on the LCD again, allowing the user to record it manually.
The numerical IOP, OPA and Q values of the last 10 measurements can be printed out as a summary report.
To do so please activate the PASCAL User Settings Menu and toggle to the item "Wireless Action" as
described in Section 5.2.1. In the "Wireless Action" menu, perform "short clicks" of the BLUE KNOB to activate
the “Print History” mode.
5.3.6. PC Transfer
When the PC mating has been once initialized, PC transfer modus has been selected, and if the receiving
software is open, the result will be automatically transmitted each time a measurement is completed. To
suppress transfer, deactivate PC transfer in the Wireless mode menu.
If an error condition is detected, the error message “NO PC access” will be displayed on the PASCAL LCD.
Ensure that your PC is close enough to the PASCAL Tonometer, that the Bluetooth USB Adapter is correctly
inserted and that the software interface program (like PDW or EMR-software) is open. Then perform a short
click with the BLUE KNOB to acknowledge. If the result will still be not transmited after 3 attempts to correct
the error condition, the message "Aborted. Note result" will appear, and the result will be displayed on the
LCD again, allowing the user to record it manually.
PASCAL is OFF short click single beep PASCAL starts up, performs internal function
(sufficient to test, then (after approx. 3 seconds) switches on
activate processor) LCD backlight and starts receiving data. If no
signal above threshold is detected, shut-down
after 60 seconds.
PASCAL is activated long click none measurement stopped. User Settings Menu is
to take measurement displayed, beginning with Prior Results list. If an
IOP was already detected in current
measurement, its result will appear in list.
measurement None double beep; Result is displayed for 20s with backlight
completed (Adequate or two double illumination, plus 40s without illumination.
Interrupt Maneuver) beeps if Q>3
within 60 seconds after long click none User Settings Menu is displayed, beginning with
measurement is Prior Results list.
terminated
User Settings Menu short click single beep selected value is incremented.
(double for
“Volume”)
User Settings Menu long click single beep scrolls to next menu item.
User Settings Menu no click within 10s none Internal memory is checked, LCD goes off
(History and System info) andPASCAL shuts down.
User Settings Menu no click within 5s none Internal memory is checked, LCD goes off and
(other items) PASCAL shuts down.
1
May be not available if the option has not been installed (cf chapter 5.3)
Fig. E
Good Tip:
no visible noise
Fig. F
Bad Tip:
noisy curve
Fig. G
Bad Tip:
Irregular curve
To perform this test, the PASCAL Test Kit (part no. 311.620.001) is required.
Performance Test mode is usually "disabled". It may be activated by executing a "short click" while the
message "Performance test disabled" is being displayed. In active Performance Test mode, PASCAL will
measure a static hydraulic pressure generated by the optional Performance Test Kit. In this mode the system
software is not looking for pressure pulsations and Interrupt Maneuvers, but instead will detect a static
pressure during a fixed time (15 seconds). Nevertheless results are handled as in the normal measuring
mode: the results are stored in the history list and will be transmitted if the tested system is a PASCAL
WIRELESS system and the printer or PC transfer options are set in the “wireless mode” item (cf section 5.3).
To check the calibration of PASCAL's pressure sensing performance, remove the tonometer from the slit
lamp and perform the following operations (procedure is also printed on the surface of the Test Kit):
1) Place PASCAL Tonometer on tonometer holder plate.
2) Place Test Container, standing on its long side into gap in holder
plate.
3) Fill Test Container with room temperature water to fill level.
4) Connect tube to SensorTip mounted in PASCAL Tonometer.
5) Push vent button for 2 seconds to vent Test Container.
6) Activate PASCAL unit (short click on BLUE KNOB)
7) Enter User Settings Menu (long click on BLUE KNOB; Prior Results
List appears).
8) Advance through menu settings until "Performance Test disabled" Fig. 18 Performance Test Kit
appears (6 long clicks).
9) Activate Performance Test (short click); "Performance Test active" appears.
10) Turn Container 90 degrees clockwise, to stand on short side.
11) Repeated beeps indicate that test is running. Wait until terminated.
Note result: Acceptable values are 15.0 ± 0.4 mmHg
12) To repeat test:
Turn Container 90 degrees counter-clockwise, to stand on long side. Repeat procedure from step 5
13) To end testing:
a) Disconnect tube from PASCAL.
b) Drain all water from Container.
c) Wait for PASCAL to shut off. Upon next turn-on, it will reset automatically to normal measurement
mode.
The result displayed should be in the range 14.6 to 15.4 mmHg. If inconsistent results are obtained from
repeated tests, or if the test result is consistently out-of-range, the SENSORTIP and the manometric test kit
should be sent to an authorized service center for inspection and repair or re-calibration.
It is recommended that the performance test be performed at regular intervals, at least once a year. The test
should be performed on all SENSORTIPs in use. If several or all of your SENSORTIPs fail the performance test,
a failure in the pressure detection circuitry of the PASCAL Main Unit must be suspected. If this occurs, the
PASCAL and all SENSORTIPs, together with the Test Kit, should be sent to the service center.
6.2.2. Cantilever Test
This test may be performed while the PASCAL Main Unit is mounted on the slit lamp, or by placing the
device upright on a flat surface and holding it firmly. Activate the CANTILEVER Test mode from within the User
Settings menu as described in Section 5.2.1, then gently move the CANTILEVER back and forth over its entire
range of travel. If CANTILEVER is in its resting (forward) position, the PASCAL will be silent. If CANTILEVER is at
or near its fully deflected position, an acoustic signal (2000 Hz beep) will be heard. If CANTILEVER is in its
correct working position for measuring patients, a lower-pitched acoustic signal (1000 Hz beep) will be
heard. The test is successfully passed if the acoustic signals in both sections of the CANTILEVER range of
travel are heard correctly. If no signals are heard, or if a signal is heard while CANTILEVER is in its resting
position, the test should be regarded as "failed".
It is recommended that the cantilever test be performed at regular intervals, every one to three months. The
test should be performed immediately if the PASCAL device was dropped, or if any other unusual force
might have been applied to the CANTILEVER.
If CANTILEVER Test fails, the PASCAL device should not be used on patients. Have your PASCAL
serviced immediately by an authorized service facility.
6.3. Cleaning
Neither the PASCAL Main Unit nor the SENSORTIPs may be sterilized.
For cleaning the Main Unit housing, tissue swabs pre-soaked with Isopropyl Alcohol are recommended
(e.g. "Alcohol Swabs" by Becton-Dickinson).
For cleaning the SENSORTIP, water only should be used. If necessary, a few drops of clear household soap
solution may be added. Avoid getting any liquid on the circuit board of the SENSORTIP. To remove dust
particles from the SENSORTIP surface, a pressurized inert gas from a spray can is recommended.
Appropriate products are available under names such as "Dust-Off" or "Dust-Free" from computer or
electronics shops, hardware stores, or drugstores.
Frequent contact with alcohol or frequent mechanical cleaning may damage the contact surface
of SENSORTIPs and may cause malfunction. Do not immerse Main Unit in water or other liquids.
Do not attempt to clean and re-use SENSORCAP disposable tip covers, as this might cause
invisible fractures of the protective membrane and hence create a contamination risk.
No servicing of PASCAL may be performed by the user, with the exception of the
functional tests described in sections 6.2.2 and 6.2.1. All service must be carried out by
the manufacturer or by an SMT-authorized service center.
Occasionally, system firmware upgrades for PASCAL may become available. Regularly check the SMT
website, or ask your distributor, for upgrade information. Such upgrades may only be performed by an
authorized service center. On PASCAL WIRELESS systems only, firmware upgrades may be performed by
the user, by means of the Downloader Untility (see section 2.2).
Should the PASCAL tonometer and / or an accessory fail to operate as expected, please proceed following
the steps outlined below:
1) Study this manual, particularly section 7 (Troubleshooting). Many apparent malfunctions may be
corrected by following appropriate troubleshooting procedures.
2) Contact your distributor by phone for advice. Some malfunctions may be easily corrected by following
simple procedures suggested by your distributor.
3) If the problem cannot be resolved on site, and if so advised by your distributor, plan to return your
PASCAL to the distributor for repair. The distributor may issue an RMA number (return material
aufhorization) which you should mark on the returned unit to facilitate tracking. In some situation, the
distributor may offer you a loaner unit to bridge the time until you receive your returned unit back.
4) If you cannot get help from a distributor, you may contact SMT directly by sending in an RMA Request /
Complaint. This may be done online by completing the online form available on the "Service and
Support" page at www.pascal-tonometer.com. Please follow the instructions provided on this webpage.
6.5. Disposal
Used battery packs should be disposed of separately, together with other used batteries. Battery Packs
contain aggressive liquids which may be harmful if spilled.
Used SENSORCAP tip covers should be disposed of with other medical office waste.
All disposal should be carried out in accordance with applicable local and national regulations.
Users within the European Union (EU), please handle electronic waste as mandated by the
European Union Directive 2002/96/EC on Waste Electrical and Electronic Equipment. For details,
see section 8.4.4.
7. Trouble
eshooting
Use the Troubleshoo oting guide and/or
a the tabble of alerts and status messages,
m prrovided below, to determ mine
the posssible causes of observed d system be ehavior, and to receive suggestions
s for appropriate action. YouY
may alsoo find the “Q
Questions andd Answers” a and the “Tips s and Tricks”” sections usseful for gettiing familiar with
w
your PASSCAL Tonom meter and for becoming m more proficie ent in its use..
7.1. Troubles
shooting guide
g
Observe
ed behavior Possible cause Action
n to take
Result shows Q score of 4 or Poor quality data (improper eye Discard measurement and repeat.
5. contact, excessive eye movement,
electronic interference)
LCD Display is blinking and Poor quality data (improper eye Discard measurement and repeat.
two double beep were heard contact, excessive eye movement,
after the interrupt manoeuvre electronic interference)
instead of one
Result shows a number for Poor quality data (improper eye Discard measurement and repeat.
IOP but “OPA = n/a” even contact, excessive eye movement,
though you can hear the electronic interference)
oscillating sound during
measurement.
Observation period was too short Repeat measurement; keep SENSORTIP on eye for
at least five waveforms of the oscillating sound.
Result shows a number for Patient has a very low OPA Device unable to detect such a small OPA. Note
IOP but “OPA = n/a”, and the (OPA < 0.5 mmHg.) OPA as “not detectable”.
sound heard during
measurement does not seem
to oscillate in pitch.
Error Message: “Check Tip!, No SENSORTIP in Tip Carrier Insert a SENSORTIP
no Tip.”
Bad contact; SENSORTIP not fully Push SENSORTIP fully into Tip Carrier; wipe contacts
inserted into Tip Carrier clean on Tip and in Tip Carrier.
Calibration value out of range or Send tip to Service Center for recalibration or
not available repair.
Error Message “Check Tip!, check of the overall pressure Send tip to Service Center for recalibration or
OTF Error.” transfer function failed repair.
Error Message “Check Tip!, redundancy check failed Send tip to Service Center for recalibration or
CRC Error.” repair.
Black square blinking on Battery almost empty Replace Battery Pack.
LCD (rightmost position)
Warning message: “battery Battery almost empty Replace Battery Pack.
low, replace soon”
Two black squares blinking Battery empty. No further Replace Battery Pack immediately.
measurements possible.
Warning message: “battery Battery empty. No further Replace Battery Pack immediately.
empty!, replace” measurements possible.
Test printout was While searching for available 1) Do not acknowledge the message “print correct,
printed on the wrong printers, another printer was found confirm=click”
printer before the wanted one. 2) Let PASCAL find another printer
3) When the test printout comes from the desired
printer, short click on BLUE KNOB to permanently
save the printer address.
ID on the LCD display While searching for available 1) Do not acknowledge the message “ID …,
does not match with computer, another PC was found confirm=click”
the one on the PC before the desired one. 2) Let PASCAL find another PC
screen 3) When both IDs match, short click on BLUE KNOB
to permanently save the computer address.
As a "last resort", if your PASCAL seems to be "frozen" or is not responding as expected, you
may try to reset the device. To do so, remove the battery, wait a few seconds, then re-insert
battery and re-start by turning the unit on (with a short click of the BLUE KNOB).
7.2. Error Me
essages an
nd Status Messages
7.2.1. PASCAL Main Unit
Messag
ge Meaning
M Action to takke
Status
S Messag ge: Wait until thee next messag
ge is displayed
d
Please wait. on the LCD.
Syystem te
est In
ndicates that sseveral internaal system
te
ests are curre ntly being perrformed.
Status
S Messagge. Do not proceeed if you have not installed
da
Reminds
R you too always use a SENSORCAP over the SENS SORTIP.
SENSORCAP annd indicates that the Otherwise, pproceed with measurement.
m
PASCAL
P is acttive and recording data.
Status
S Messag ge: (none)
pow
wering down
d In
ndicates that a memory testt is
performed
p andd that the syste
em is
powering
p down n.
Error
E Message e: Push SENSO RTIP fully into Tip Carrier;
Bad
B contact orr SENSORTIP not fully wipe contactts clean on Tip
p and in Tip
C
Check Tip! Carrier.
in
nserted into Tiip Carrier.
No Tip.
Calibration
C valuue out of rang
ge or not
available.
a
Error
E Message
e. Send tip to S
Service Center for
C
Check Tip! recalibration or repair.
C
CRC Error. Redundancy
R c heck failed.
Error
E Messagee: Send tip to S
Service Center for
C
Check Tip! recalibration or repair.
O
OTF Error. Overall
O pressu re transfer fun
nction check
fa
ailed.
Error
E Message
e: Let the PASC CAL Tonometter power dow wn
Che
eck memo
ory! and restart itt. If the problem persists, then
The
T memory iss corrupted.
send the maain unit to Serv vice Center
Alert
A Message (blinking curs sor appears Energy left foor a few meas
surements.
in
n addition to ccurrent display
y). Have new Baattery Pack re eady.
Battery
B Warnin ng.
Alert
A Message : Energy left foor a few meas
surements.
Ba
attery lo
ow! Battery
B Warnin
ng displayed in
n alternance Have new Baattery Pack re eady.
Re
eplace so
oon w the resultss or error messages.
with
Alert
A Message (second curssor appears No energy leeft. No further measurementts
in
n lower right p
position): possible. Reeplace Battery Pack
Battery
B Alert. immediately..
Alert
A Message : No energy leeft. No further measurementts
Bat
ttery empty! Battery
B Alert diisplayed in altternance possible. Reeplace Battery Pack
Replace
e with
w the resultss or error messages. immediately..
Messag
ge Meaning
M Action to takke
Communication
C ns Interface Status:
S Connection tto target devic
ce established
d.
Wireless
W modu
ule active.
Communication
C ns Interface Status:
S Main Unit is sending data to target
Wireless
W data ttransfer active
e. device.
Printer
P Alert Me
Message: Is printer clos
ose enough to PASCAL?
Connection
C to printer was no
ot Try moving itt closer, and retry.
r
established
e or printer was bu
usy. Is printer swiitched on? Reefer to section
7.2.4 to checck printer statu
us.
Printer
P Alert meessage: 1) Ensure thaat the cover iss closed
There
T is no ressponse from th
he printer. 2) Click on thhe single Printter button untiil
paper is fed
3) Click on B LUE KNOB with hin 60 sec.
Printer
P Alert meessage: Send Printeer to Service Center
C for repa
air.
Printer sensor Printer
P paper ssensor is malfu
unctioning.
problem
m
Printer
P Alert me
essage: 1) Load a neew roll of therm
mal paper.
Pri
inter paaper No
N paper or the e printer cove
er is open. 2) Close trannsparent coveer lid of printer..
problem
m
3) Click on B LUE KNOB withhin 60 sec.
Printer
P Alert me
essage: Print head iss overheating. Switch printer
Pr
rinter he
ead High
H temperatu ure. off and allow
w to cool. If pro
oblem persistss,
problem
m contact Servvice Center.
Printer
P Alert me
essage: 1) Plug the pprinter into wall outlet
Prin
nter batttery The
T printer is rrunning on low
w battery. 2) Click on B LUE KNOB with hin 60 sec.
problem
m
Printing
P Aborteed Error: Perform shoort click of BLUE KNOB once to t
Attempts
A to pri nt have failed. re-display reesult. Note result manually.
Messag
ge Meaning
M Action to takke
Communication
C ns Interface Status:
S Connection tto target devic
ce established
d.
Wireless
W modu
ule active.
Communication
C ns Interface Status:
S Main Unit is sending data to target
PC
P was found and responde ed correctly. device.
Wireless
W data ttransfer active
e.
PC
P Alert messa age: 1) Ensure thaat the USB Ad dapter is
The
T previouslyy assigned PC C was not inserted andd is within 10m
m (30 feet) awa
ay
No PC available
a after a timeout of 2.5
2 minutes. from PASCA AL Tonometer
access 2) Click on B LUE KNOB with hin 60 sec.
3) If the probblem persists, close all
applications and restart yoour PC
PC
P Alert messa age: 1) Ensure thaat the PDW innterface
The
T previouslyy assigned PC C is found, program is ruunning and coorrectly set up
but
b it is not or iincorrectly res
sponding. 2) Ensure thaat no other programs are
currently usinng the same COM
C port
3) Click on B LUE KNOB withhin 60 sec.
Printing
P Aborteed Error: Perform shoort click of BLUE KNOB once to t
Attempts
A to pri nt have failed. re-display reesult. Note result manually.
Blue L
LED blinking rapidly Resettable
R erroor (printer hea
ad over- Printer battteries may be low. Replace
heating,
h or batttery voltage error). or rechargee (if rechargea able). Or:
Print head may be overh heating. Switch
printer off aand allow to cool. If problem
m
persists, coontact Servicee Center.
Blue
e LED blinking very Printer
P is shuttiting off.
rapidly
Adapter connected.
A device is connected to
COM5 of the USB adapter.
More detailed information can be found in the specific user manual for the PASCAL DATA WIZARD.
Q: My results with PASCAL differ from the values I get with the Goldmann Tonometer.
A: Applanation Tonometer measurements are subject to systematical errors if corneal thickness, radius,
and rigidity deviate from values typical for a “standard cornea”. IOP estimates from Applanation
Tonometers are therefore likely to be different from Contour Tonometer measurements in most cases.
Contour Tonometer readings are most likely a more accurate representation of true intra-ocular
pressure.
Q: Sometimes I cannot hear any sound during the measurement, although I am getting a result that looks
plausible.
A: You may be touching the eye before the LCD display screen has initially illuminated following activation
of the PASCAL with the BLUE KNOB. During activation, the PASCAL performs a self-test and sets the
current pressure reading to zero. If the SENSORTIP is already in contact with the eye at this point, no
further pressure increase will be detected and no sound will be heard. Nevertheless, the PASCAL is
acquiring data, and after the Interrupt Maneuver the software will usually be able to retrieve the correct
IOP value from the data.
Q: I cannot find the “PC transfer” option on my PASCAL Tonometer.
A: The “PC transfer” option is only available in Firmware version v3.10 and higher. Once the version has
been installed on your PASCAL Tonometer, the option has to be released by use of a unique activation
key code which can be purchased from the PASCAL website.
Q: Can I have several printers/PC operating simultaneously in my office?
A: Yes. Upon initialization, each printer/PC is assigned to its PASCAL unit, and once this has happened,
each PASCAL will only talk to its assigned printer/PC. To initialize the printing/ data transfer function of
your PASCAL and to assign a specific printer/PC to it, all other printers present should remain switched
off during the initialization procedure.
Q: Can I use one and the same printer/PC for all PASCAL units in use in my office?
A: Yes. The printer/PC will get the results from all PASCAL units to which has been assigned, provided
they are within range. Each printout/transferred data will contain the serial number of the PASCAL unit
which has sent that specific data set. Printing/Transferring to the same device from several PASCAL
tonometer may create a risk of data confusion and data congestion. Therefore, be careful to properly
identify each printout.
8. Appendix
8.1. Dynamic Contour Tonometry
8.1.1. Functioning principle of Contour Tonometry
The Contour Tonometer (Fig. 19) consists of a cylindrical tip with a surface contour which closely resembles
the contour assumed by the cornea when pressure on both sides is equal. When held against the cornea
with a constant, small appositional force F, cornea and tip will be in direct contact in a circular area with
diameter d (“contact area” AC). Within the contact area, the cornea thus assumes the above mentioned,
matched contour. The distribution of external forces between tip and cornea matches the internal force
generated by IOP. A change in the appositonal force F will cause d to change, but will not affect the force
distribution, provided the diameter of the tip is larger than d.
The radius of curvature RT used for the SENSORTIP is slightly larger than the curvature radius RC of the
cornea in its natural, unloaded state. The forces FP exerted by intra-ocular pressure P generate tangential
tensions in the cornea. Within the contact area, the same forces F act at both sides of the cornea and thus
cancel. Hence, no tangential tensions are generated within AC. Tangential tensions in the neighborhood of
area AC act along its rim to generate concentric forces pulling on the cornea and thus flattening the corneal
contour across AC; i.e. the radius of curvature RC will increase by a small amount ∆R relative to the normal,
force-free situation and will become equal to RT. Within contact area AC, the contours of the tip and of the
cornea thus ideally match. This condition shall be termed “Contour Match”.
In the Contour Tonometer, the applanation force F is maintained at a constant value by the device’s
CANTILEVER mechanism. The diameter d of the contact area AC will vary, depending on the conditions
required to achieve contour match, and will not be relevant for the measurement. The Contour Match
condition establishes itself irrespective of thickness or original shape (curvature) of the cornea, provided that
the original corneal radius RC is smaller than the tip curvature RT. As the Contour Match condition is thus
automatically fulfilled, pressure on either side of the cornea will be equal; i.e. the pressure measured by the
pressure sensor built into the tip will correspond exactly to intra-ocular pressure. Therefore, the output from
the pressure sensor provides a direct measurement of IOP.
8.1.2. Comparing with applanation tonometry data
An important consequence of the design characteristics discussed above is that the pressure measurement
furnished by the Contour Tonometer is independent of corneal radius, corneal thickness, corneal rigidity, and
hydration, as long as a few conditions are met:
Corneal radius must be smaller than the curvature radius of the Tonometer Tip. The PASCAL
SENSORTIP has been designed so as to ensure that this condition is met for all corneas with a radius
of curvature not exceeding approximately 10.4 mm (i.e. keratometric diopter value should be larger
than 32.5).
The diameter of the contact area must be larger than the diameter of the pressure sensor area. With
steeper corneas (small corneal radius), the contact area becomes smaller, posing a limit on corneal
radii with which the Contour Match condition can be correctly established. From experiments and
calculations, this lower limit for corneal radius is approximately 5 to 6 mm (55 to 65 keratometric
diopters).
Corneal thickness and rigidity must be such that the cornea can change its curvature, as dictated by
the contour match condition, without any significant force being required. Experiments and theoretical
calculations have demonstrated that this condition is met for corneal thicknesses ranging from 300 to
700 microns.
The Contour Tonometer will thus furnish correct pressure measurements from essentially all human corneas,
with the possible exception of extremely flat or irregular corneas that may be encountered after keratoplasty,
or as a result of scarring.
In contrast, the functioning principle of Applanation Tonometers (in particular the Goldmann Tonometer) is
based on measuring the force required to achieve a specified deformation of the cornea. The Goldmann
Tonometer is designed to furnish a correct pressure measurement when applied to a “standard cornea” with
a thickness of 537 microns and a radius of 7.8 mm. The more a given cornea deviates from these values, the
larger the systematic error inherent to the method. Many studies have demonstrated that corneal thickness
has a particularly noticeable effect, and various correction nomograms have been proposed which claim to
correct applanation tonometer readings for corneal thickness. However, the deformation characteristics of
individual corneas also vary significantly due to subtle differences in structural integrity which cannot be
quantified. A particularly striking example is the profound effect of dissection or removal of Bowman’s
membrane resulting from corneal refractive surgery (LASIK or PRK). On such eyes, Goldmann Tonometers
have been shown to furnish false low results by 5 mmHg or more.
Furthermore, as pointed out already by Hans Goldmann in his original work on Applanation Tonometry, the
Goldmann Tonometer has a general systematic error of –1 mmHg, even on the standard cornea. The
PASCAL Contour Tonometer has been calibrated to give a precise measurement of true intra-ocular
pressure.
As a consequence of the fundamentally different measuring principles and the behavior described above,
IOP readings from the two types of Tonometers will usually not agree. The Goldmann Tonometer (as well as
any other Applanation Tonometer) is not a precise pressure measuring device and should therefore not be
used as a standard against which to compare the precise measurements of the PASCAL Contour
Tonometer.
8.1.3. "Unexpectedly different" results
Occasionally you will see PASCAL results that differ considerably (by several mmHg) from IOP estimates
obtained with applanation tonometers. "Strange behavior" is primarily encountered with thicker than normal
corneas, but my also be seen with other corneas.
Major differences are to be expected whenever the biomechanics (elasticity, rigidity, hydration, linking of
stromal lamellae, etc) differ from the assumed properties of a hypothetical "standard cornea". These
differences are largest, and easy to understand and accept, when we are dealing with a surgically altered
cornea (e.g. by LASIK or LASEK or PRK; as described in several papers). But differences are also known to
exist in corneas of people with ocular diseases (e.g. Glaucoma, Diabetes), or under the influence of certain
drugs (e.g. some types of Glaucoma drops). Differences may also exist, and have been found, even in
healthy subjects.
Variations in corneal thickness are well known to produce deviations in applanation IOP. However, different
reports have proposed different numbers to be used for correction nomograms. Corneal thickness is easy to
measure; therefore it is tempting to try and correct false IOP readings by pachymetry. This works best for
homogeneous populations of healthy subjects (e.g. healthy, 30 yr old Caucasian men). In a typical,
heterogeneous population of patients seen in a typical doctor's office, the correlation between CCT and
applanation IOP will all but break down. For post-LASIK/PRK patients, pachymetry-based correction
nomograms may even produce results with the wrong sign. This is due to the fact that the effect caused by
biomechanics is often much larger than a CCT effect. Biomechanical properties are, for all practical
purposes, not amenable to measurement.
As evidenced by the increasing number of studies published, Contour Tonometry is much less dependent on
biomechanical variations than applanation tonometry. For all practical purposes, it seems to be safe to say
the PASCAL measurement is factually independent of biomechanics, bulbus geometry, or refraction.
A careful study, performed with human cadaver eyes, has proven that DCT measurement agrees very
closely (better than 1mmHg) with the true IOP measured manometrically inside the bulbus. And initial results
(unpublished) from intra-cameral measurements on live eyes (performed during cataract surgery) seem to
confirm these findings.
Therefore, if someone finds, for example, 15 mmHg with Goldmann and the same result with an air
tonometer, but, say, 19 mmHg with the PASCAL, such a result is not at all "impossible" or "incredible" or
"false". It may be hard to believe against a background of decades of experience with what is still referred to
as a "Gold Standard". However, people should be reminded that it is a proven fact that applanation delivers
false results in certain circumstances. What is less well known is just how large the error can often be.
Of course, any instrument may furnish faulty results under certain conditions. This can certainly also happen,
and has been seen, with the PASCAL tonometer. Possible reasons may be:
PASCAL tip not correctly centered on the eye.
Extremely flat corneas which adhere to the entire tip surface.
SensorCap not properly mounted -- air bubbles or wrinkles in the membrane.
Physically damaged SENSORTIP, with an uneven surface (e.g. caused by partial delamination of the
coating of the contact surface, or mechanical damage caused by attempted vigorous cleaning).
Poor data quality (with a Q > 3), due to poor patient cooperation, or too short measurement time, or low
OPA (<1 mmHg).
Poor lacrimation of patient’s cornea; or excessive lacrimation. These two conditions can have a major
effect on the quality of the data generated, and need to be managed carefully. This topic will be
discussed in detail further below (see section 8.1.4).
It is therefore always a good practice to check your result (including the Q value shown on the LCD) and
your instrument (whether it looks initially "believable" or not) and, when in doubt, to perform a second
measurement. Most of the conditions which may give rise to errors can be seen and corrected when
carefully observing the cornea – tip interface.
Only a minority of the potential causes for measurement errors listed above are patient-related. These
deserve special discussion as they can be managed if their consequences are properly understood.
8.1.4. Dealing with lacrimation
Excessive lacrimation: If there is too much liquid on the cornea, the SENSORTIP may actually not touch the
eye. It will "float" on the excessive liquid (this may happen more frequently with flat corneas than with steep
corneas; Fig. 20). In this case you are likely to get very low IOP values and no real oscillation (irregular
curve, irregular sound with no clear oscillation pattern; often poor Q value). Removing the excess liquid from
the eye and from the SENSORTIP will help to get a correct measurement.
Poor lacrimation / dry eye: For PASCAL measurements it is important to have a complete tear film
between cornea and SENSORTIP surface. If part of the interface is completely dry, this may cause the cornea
to stick to the SENSORTIP. If that happens, you will notice that when moving the slit lamp, the contact area will
not move freely, but the eye is pulled along with the SENSORTIP. It is easily seen that this will cause extreme
distortion forces to occur in the cornea, leading to readings which may be up to 2x IOP. Another situation
that may occur with poorly wetted corneas is that you do not see a complete circular contact area, but a
contact area with irregular borders (this is most frequently seen on the top part which tends to run dry first
due to gravity; Fig. 22). In this situation it may help to add some liquid (artificial tears, preferably a low
viscosity variety; or more anesthetic drops). Incidentally, this situation may also occur in applanation
tonometry. But if there is insufficient liquid, there will be insufficient Fluorescein and therefore no fluorescent
ring, prompting the observer to almost automatically instill some more drops. Insufficient lacrimation also
creates a risk of epithelial erosion from moving around with the tip (Goldmann or PASCAL) on the cornea.
Hence two important rules:
Excessive lacrimation: low PASCAL readings. Remove excess liquid.
Poor lacrimation: high PASCAL readings. Add drops.
Fig. 20: excessive lacrimation: entire Fig. 21 regular pattern: contact area is Fig. 22 poor lacrimation; tear-film
lens filled with tear fluid. circular and smaller than total breaks up from top.
lens diameter.
All this is not fundamentally different from applanation tonometry. Experienced, careful observers will take
those same precautions also with the Goldmann. But other observers may be satisfied doing a "quick and
dirty" IOP with the Goldmann, touching the cornea merely for a few tenths of a second. Goldmann technique
appears to be more "forgiving" (actually, deceptively forgiving - users think they are getting a good reading
when they are, in reality, merely guessing at a result in an unstable situation).
8.1.5. Dynamic Tonometry vs. Static Tonometry
The pressure sensor of the PASCAL Tonometer has a very fast response to rapid pressure changes. It is
capable of recording the pressure fluctuations originating from pulsatile ocular blood flow and other
physiological effects in real-time. The signal processing software determines the lower (diastolic) and upper
(systolic) limits of the intra-ocular pressure. The difference between the two is referred to as “Ocular Pulse
Amplitude (OPA)” and is displayed along with the base (diastolic) IOP on the PASCAL’s LCD display. The
IOP may be regarded as the static component of intra-ocular pressure, while the OPA in addition provides
elementary information about the dynamic component inherent to intra-ocular pressure.
Most Applanation Tonometers provide only an estimate of the static IOP component. Depending on
individual technique, the static IOP estimate may be indicative of the lower or upper IOP limit, or to some in-
between “pseudo-steady-state” value.
initialize
beep SENSORCAP
Reminder
Recording Mode
Recording
Message
NO History
Interrupt? List
YES
2xbeep Settings*)
Stop recording
Compute
Display
Result
(Wireless enabled systems only)
Long Click
NO
YES YES
Print Report Printer on
NO
Shut Off
Fig. 16
Dimensions, Weight: 14.5 x 18.5 x 6.5 cm; 800 g (complete shipping weight)
Temperature: 0 – 50°C
Relative humidity: 10% - 85%
Power Supply:
primary voltage: 100 – 240 V AC ± 10%
secondary voltage: 15 V DC; 600 mA
Outlet plug adapters: Swiss, Euro, USA, UK, Australia
Manufacturer (Printer): Custom Engineering SPA
Str. Berettine 2, 43010 Fontevivo (Parma), Italy
phone: +39 0521 680 163
www.custom.it
Manufacturer (Power Supply): ANSMANN ENERGY GMBH
Industriestr. 10, D-97959 Assamstadt, Germany
phone: +49 6294 4204-0
www.ansmann.de
PASCAL systems must be ordered with either S1-type bracket (see Fig. 4, page 12) or S2-type bracket (see Fig.
5, page 12) as required if you plan to suspend the unit using its mounting bracket. (Appropriate part numbers are
listed below). If mounting bracket is not used (device mounted using a footplate adapter), either a S1- or S2- type
unit may be used.
311.001.001 / 002 PASCAL System Complete System, standard version, based on S1 or S2 Main Unit
S1 / S2
311.101.001 / 002 Main Unit S1 / S2 Main Unit (standard version) with S1 / S2-type mounting bracket
311.011.001 / 002 PASCAL Complete System, wireless-enabled version, based on S1 or S2 Main Unit
WIRELESS System
S1 / S2
311.111.001 / 002 Main Unit, Main Unit (wireless-enabled version), with S1 / S2-type mounting bracket
WIRELESS
311.640.001 / 002 Attachment Kit S1 / Attachment screws and Torx wrench for S1/S2-type Main Units
S2 (System includes appropriate Attachment Kit)
311.510.102 SensorTip (System includes one SensorTip)
311.751.102 Battery Pack (System includes one installed battery plus a reserve battery)
311.701.205 AppliPack (System comes with 24 SensorCaps in AppliPack packaging)
311.400.020 PASCAL (System comes with this small utility program and its corresponding user
Downloader manual)
311.951.001 User Manual (System comes with a User Manual in English; supplied on CDROM)
311.951.101 Quick Reference (System comes with a laminated Quick Reference Sheet in English Language).
Sheet
WARNING
The use of accessories, transducers and cables other than those specified may result in increased
emissions or decreased immunity performance of the equipment or system.
Table 201:
Table 202:
Guidance and manufacturer’s declaration – electromagnetic immunity
The EQUIPMENT is intended for use in the electromagnetic environment specified below. The customer or the user of the
EQUIPMENT should assure that it is used in such an environment.
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be at levels
(50/60Hz) magnetic field characteristic of a typical location in a typical
IEC 61000-4-8 commercial or hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
Table 204:
Guidance and manufacturer’s declaration – electromagnetic immunity
The EQUIPMENT is intended for use in the electromagnetic environment specified below. The customer or the user of the
EQUIPMENT should assure that it is used in such an environment.
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
Fixed 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
access the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be
considered. If the measured field strength in the location in which the EQUIPMENT is used exceeds the applicable RF
compliance level above, the EQUIPMENT should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the EQUIPMENT.
b
over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 206:
Recommended separation distances between
portable and mobile RF communications equipment and the EQUIPMENT
The EQUIPMENT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the EQUIPMENT can help prevent electromagnet interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the EQUIPMENT as recommended below, according to the
maximum output power of the communications equipment.
Disposal of The electronic components of the PASCAL® Dynamic Contour Tonometer are subject to the European Union Directive
Equipment 2002/96/EC on Waste Electrical and Electronic Equipment. This directive applies to all electronic equipment in the
European Union only.
The disposal to municipal waste is prohibited for electronic equipment subject to this directive; this equipment must be
collected separately and treated or recycled. Electronic equipment that is subject to this regulation is marked on the
components itself with the symbol on the left.
The PASCAL® Dynamic Contour Tonometer contains the following electronic parts which are denoted with this specific
symbol: PASCAL Main Unit (311.101.001 and 311.101.002 - Standard PASCAL); (311.111.001 and 311.111.002 -
Wireless PASCAL); Rechargeable Battery Kit (311.761.001); Rechargeable batteries, package of 2 (311.761.005);
Replacement batteries (not rechargeable), package of 5 (311.751.002)
This electronic equipment has required the extraction and use of natural resources for its production. It may contain
hazardous substances that could impact health and the environment. In order to avoid the dissemination of these
substances in our environment we encourage you to use the appropriate take-back systems. Those systems will reuse
or recycle most of the materials of your end life equipment in a sound way.
Treatment and/or recycling of electronic equipment from the PASCAL® Dynamic Contour Tonometer are provided at
no cost to you. Please see the contact information below for disposition of unwanted SMT electronic equipment.
Address SMT AG
Allmendstrasse 11
CH – 2562 Port (Switzerland)
Contact phone number +41 32 332 70 80
Email customer.service@ziemer-ophthalmics.com
Optional Accessories:
311.660.001 PASCAL Printer Wireless printer, battery operated. Compatible with PASCAL WIRELESS systems
only. Uses standard AA disposable or rechargeable batteries and standard thermal
printing paper (58mm wide roll paper).
Note: Consumables for the printer may be obtained from any office supplies store
(not available from PASCAL manufacturer / suppliers)
311.640.005 Adapter Kit for mounting the PASCAL Main Unit on Haag-Streit-type slit lamps. Includes
PASCAL FOOTPLATE and BASE PLATE.
(Adapter Kits for other types of slit lamps are available on request)
311.510.002 SensorTip Single SensorTip, as back-up or replacement for the one included with the basic
system.
311.510.003 SensorTip-3 Package containing 3 SensorTips.
311.761.001 Rechargeable Battery Charger Kit (110/220V), with two rechargeable batteries (to be used in lieu
Battery Kit of disposable batteries included with System).
311.620.001 Test Kit for performing pressure sensor calibration checks.
311.951.002 Other Language PASCAL® User Manual in foreign language versions; electronic version, PDF
User Manuals Format, on CDROM.
Consumables:
311.751.002 Replacement 5 disposable batteries, as replacement for the 2 batteries included with system.
Batteries, NOT RECHARGEABLE.
disposable
311.761.105 Replacement 2 rechargeable batteries (Battery Charger p/n 311.761.001 is required).
Batteries,
rechargeable
311.701.201 SensorCaps-240 Box containing 240 sterile SensorCaps (sterile, disposable protective tip covers,
each in an AppliPack for easy mounting.