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User Manual

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

Distributed by ZIEMER OPHTHALMIC SYSTEMS AG, CH-2562 Port, Switzerland. www.ziemer-ophthalmics.com


USER MANUAL

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 

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USER MANUAL

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 

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USER MANUAL Introduction

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:

1.2. Indications for use


The PASCAL® Dynamic Contour Tonometer is a diagnostic device that serves for measuring intra-ocular
pressure (IOP) according to the Dynamic Contour Tonometry method (see Appendix, section 8.1). The
device is also capable of measuring short term pressure fluctuations within the eye. PASCAL is especially
indicated in Glaucoma.

1.3. General description


The PASCAL Dynamic Contour Tonometer is a novel kind of Contact Tonometer intended for use by
ophthalmologists and optometrists and any professional eye care staff trained in the use of diagnostic
devices based on superficial eye contact.
PASCAL is an accessory device for a slit lamp. Installed into the optical axis of the slit lamp, it gives the user
a view of the contact interface between cornea and tonometer tip. A pressure-sensing tip with a contoured
contact surface, called the SENSORTIP, is applied to the center of the patient's cornea with a small, constant
force. The pressure sensor built into the contact surface of the SENSORTIP generates an electrical signal
which is proportional to the IOP. As an audible feedback, the Main Unit generates an audio signal whose
pitch is proportional to the IOP detected; the higher the pressure, the higher the pitch. The pressure signal is
detected for a period of about 5 seconds (corresponding to approximately 5 to 10 heartbeats); then the tip is
pulled away from the eye ("the Interrupt Maneuver", or simply “the Interrupt”).
PASCAL software computes IOP and its variation (modulation) caused by cardiac pulsation (Ocular Pulse
Amplitude, OPA) from the pressure-dependent electrical signal and from the signal level after the Interrupt.
These signals are stored and processed in the Main Unit and the numerical results are displayed on an LCD
display screen.

"systolic IO P" O PA

Fig. 1 Typical pressure curve, recorded for approx.


7 seconds. Several ocular pressure
pulsations are recorded, from which
(diastolic) IOP PASCAL software computes IOP
10
(referenced to zero pressure as detected
Pressure (mmHg)

Interrupt after the Interrupt), and OPA.


Start

Note: Pressure curve as illustrated here cannot be


Zero pressure reference observed with the basic PASCAL device.
Only the numerical result is presented to
0
user. Curve may be viewed as an output of
the optional Printer accessory.
0 5
Tim e (seconds)

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USER MANUAL Introduction

1.4. How to use this manual


Before using the PASCAL Dynamic Contour Tonometer, study this User Manual carefully to develop a
thorough understanding of instrument assembly and function, and of safety and hygiene precautions.
This manual is about using the PASCAL Tonometer. It does not provide instructions on how to use IOP
measurement data as an element of clinical diagnosis or on how to clinically interpret the results of IOP
measurements.

To just learn how to take a measurement, go directly to Sections 4.3 "Preparations",


and 4.4, "Taking Measurements".

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.

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USER MANUAL Introoduction

1.4.1. Explanatio
on of symbo
ols

Symbolss used in this manual: Symbols us


sed on produuct and packa
age labeling::

er must conssult User Man


Use nual before
Warning
ope
erating the deevice.

Caution Typ
pe BF appliedd part.

Note CE--Mark (Confoormité Europ


péenne)

Connsumable iteem for single use. Do not


endation, hellpful tip
Recomme
reuse.

Exppiration date (do not use product after


Video clip
p available
indiicated date)

Features available on PASCAL


Sterile product ((gamma sterrilized)
WIRELES SS systems only
o

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

 Manufacturer's part no. / ord


der no.

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G, Switzerland
USER MANUAL System Components

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

Front side Back side


(as seen by patient) (as seen by user)

SENSORTIP™ (removable)

TIP CARRIER

CANTILEVER

MOUNTING BRACKET

Main Unit Housing

Battery Pack

Liquid Crystal Display (LCD)

Control Switch (“BLUE KNOB”)

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.

2.2. PASCAL Firmware


The integrated microprocessor operates on a specific firmware, the device’s software. This firmware
can be easily upgraded and new features, such as the PC transfer option, can be released via a
wireless interface by means of the PASCAL Downloader, a small utility program. This utility program,
which is provided on the CDROM distributed with all PASCAL systems, serves for transfering
("downloading") new firmware releases from a Personal Computer to a PASCAL Main Unit. The
PASCAL Downloader is compatible with "wireless-enabled" PASCAL WIRELESS Tonometer systems
only. The program requires a unique system-dependent key code, which may be purchased from the
PASCAL website, for activation of certain features.

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USER MANUAL System Components

2.3. Accessories and Consumables


(see the table in the Appendix (section 8.5)).
2.3.1. PASCAL Wireless Printer
A small, portable, wireless printer is available as an optional accessory. It is compatible with "wireless-
enabled" PASCAL WIRELESS Tonometer systems only.
2.3.2. Adapter Kit for Haag-Streit-type Slit Lamps
An Adapter Kit (Ref. 311.640.005), consisting of a BASE PLATE and a FOOTPLATE, is available, as an optional
accessory, for mounting the PASCAL device on Haag-Streit slit lamps. The FOOTPLATE has a peg that fits
into the hole on the central slit lamp axis, in lieu of the original Haag-Streit base plate used to align a Hruby
Lens. The FOOTPLATE will also fit onto most Haag-Streit-type "clone" slit lamps from other manufacturers.
The standard Adapter Kit will be appropriate for all Haag-Streit-type slit lamps where the vertical distance
from the hole on the central slit lamp axis to the optical axis of the microscope is 17.4 cm (approx. 6 7/8"). For
models with different vertical distances, special Adapter Kits are available on request.
2.3.3. Swing Arms for various types of slit lamps
A variety of “swing arms”, for attaching PASCAL to various types of slit lamps are available. For selected slit
lamp models, pre-configured arms are available. A general-purpose kit can be ordererd for other, less
common types of slit lamps. Please consult a current price list for available types.
PASCAL is fitted on a swing arm as described in 4.1.1. When selecting a swing arm, please note whether
your PASCAL is of type S1 or S2 by consulting Figs. 4 and 5.
The complete Adapter Kit (311.640.005) contains the following items: 1 Base plate (311.640.006), 1 Key pin
(311.640.103), and 1 FOOTPLATE A (311.640.007).
FOOTPLATE A suits all Haag-Streit slit lamps and their clones except model BC.

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).

2.3.4. Test Kit


The PASCAL Test Kit is an optional accessory. It consists of an apparatus which allows the user to check
the proper calibration of their SENSORTIPS. Users who do not purchase the test kit may have these functional
tests performed by an SMT-accredited Service Center.
2.3.5. Additional SENSORTIPS
In its basic configuration, a PASCAL system comes with one exchangeable and reusable SENSORTIP.
Additional SENSORTIPS may be purchased separately. Each SENSORTIP is individually calibrated at the
factory. The appropriate calibration value is stored in the SENSORTIP’s circuitry and is automatically
recognized by the Main Unit.

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USER MANUAL System Components

2.3.6. SENSORCAP™ Disposable Tip Covers


SENSORCAP Disposable Tip Covers, made from medical-grade silicone, are placed over the SENSORTIP for
each use 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 packaging serves as a tool to simplify the fitting of a
SENSORCAP over the SENSORTIP before use. AppliPacks and SENSORCAPs are single-use and must be
discarded after use. An initial supply of SENSORCAP™ tip covers comes with the system. Additional
SENSORCAPs are available in quantities of 240 per box. The PASCAL should always be used with a fresh
SENSORCAP for each patient.
2.3.7. Non-rechargeable Battery Packs
Please contact your distributor to purchase additional disposable single-use battery packs (available in
packages of 5), and make sure to have at least one battery pack ready as a replacement when the original
battery pack runs low. A non-rechargeable battery pack will last for several months, depending on frequency
of use.
2.3.8. Rechargeable Battery Packs
As an alternative to the non-rechargeable battery packs supplied with the PASCAL systems, rechargeable
battery packs are available as an option. The optional Rechargeable Battery Kit includes a battery charging
base and two rechargeable battery packs. Rechargeable battery packs may be left charging in the battery
charging base without worry of over-charging.

2.4. Additional required material (not supplied)


The PASCAL Tonometer requires a standard slit lamp microscope, on which it is mounted for operation.
Most commonly used types of slit lamps may be used in conjunction with PASCAL. The Main Unit can
usually be mounted directly, by means of the Mounting Bracket or BASE PLATE, in lieu of the Goldmann
Tonometer.
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 water on the circuit board of the SENSORTIP. To remove any dust
particles from the SENSORTIP surface, a pressurized inert gas from a spray can is recommended. Blowing
off particles sticking to the tip surface often works best if done while SENSORTIP is still wet. Appropriate
products are available under names such as "Dust-Off" or "Dust-Free" from computer/electronics shops,
hardware stores or drugstores.
For topical anesthesia of eye(s) to be examined, low-viscosity anesthetic eye drops (e.g. proparacaine,
tetracaine, oxybuprocaine, novesine) are required. Fluorescein is not necessary.

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USER MANUAL Safety Instructions

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).

3.2. Patient Safety


Always apply topical anesthesia before using PASCAL on patient’s eye.

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.

3.3. Operational Safety


Do not soak or immerse SENSORTIPs in any liquids. Electrical contacts and electronic components
may get irreversibly damaged.

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.

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USER MANUAL Safety Instructions

(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.

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USER MANUAL Proocedures

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.

4.1. System set-up


s
4.1.1. o your slit la mp
Attaching PASCAL to
There arre multiple ways
w of attach
hing the PAS SCAL Main Unit
U to a slit la
amp, dependding on type of slit lamp and
a
tonomete er attachmennt bracket avvailable with your slit lamp:
a) Manny slit lampss have a sh hort swing arm bracket, attached d either on top or on the t side of the
micrroscope, from m which a tonnometer is s uspended. The
T bracket holds
h the tonnometer by either
e one scrrew
and two centerin ng pins (S1 mount;
m Fig. 4
4), or by two screws (S2 mount;
m Fig. 55) which atta
ach to the top
p of
the ttonometer. Unscrew
U the Goldmann ttonometer an nd attach the
e PASCAL toonometer in its place, ussing
the ffixtures on th
he Mounting Bracket and the screws provided with h the PASCA AL system.
Fig. 3 P
PASCAL mounte
ed on short swing Fig. 4 Mounting Bracket with S1 guides Fig. 5 Mounting Brack
ket with S2 guid
des
a
arm bracket

PASCAL must be ordered with w either S1-tyype bracket or S2-type


S brackett,
as required, if you plan to suspend
s the uniit from its mountting bracket ontto
ng arm.
a short swin

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.

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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

OOn some slit lam


mps, the receptacle for the FOO
OTPLATE peg may be corroded, impeding easy y insertion of th
he peg. Use fine
e
ssandpaper to rem
move any corrooded material annd to ensure an easy fit for the FOOTPLATE.

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.

4.1.2. Readyying PASCA AL for taking g measurem ments


1) Rem move PASCA AL Main Unit from the carrrying case.
2) Insert a battery pack,
p making g sure it snapps into place and will not fall out whenn tilting the device.
d
3) Insta all PASCAL on o your slit laamp using on ne of the pro
ocedures des scribed in secction 4.1.1 oben.
o
4) Prep pare a SENSO ORTIP by fittinng a SENSOR RCAP as desc cribed in section 4.2.1 unnterhalb.
5) Hold ding the prep pared SENSO ORTIP betwe en thumb an nd forefingerr so that thee surface witth the electrrical
conttacts is facin ng down, ins sert the SEN NSORTIP into the Tip Carrrier. To fac cilitate this process, the Tip
Carrrier may be rotated
r out of
o its operatinng position too either side (by a maxim mum of 90°). Supporting the
Tip C Carrier with your oppositte hand, gen ntly push thee SENSORTIP into the Tipp Carrier all the t way. Rottate
the TTip Carrier back into its operating
o possition and ma ake sure it is s properly aliggned with the optical axiss of
the sslit lamp.
6) Lookking through h the left ocu ular of the sslit lamp miccroscope, you should noow see straig ght through the
SENS SORTIP. The microscope e's magnifica tion should beb set to a moderate
m levvel (e.g. 16x). The presssure
senssor should be e visible as a greenish ssquare in the e center of a white circulaar spot in the e center of your
y
visua al field. The vertical liness you see be elow the pres ssure sensorr are the elecctrical wires that connecct to
the ccomputer. Any A other line es in your viisual field are
e probably wrinkles
w in thhe SensorCa ap which sho ould
be rremedied be efore procee eding. If the e pressure sensor
s appeears to be ssubstantially off-center, the
PAS SCAL unit ma ay have to be realigned ffor your slit lamp. Contac ct your distribbutor or SMT T Service if you
y
need d help with thhe alignmentt.
7) Yourr PASCAL device d is now
w ready for o operation. You
Y may wish to test its operation by activating the
startt switch: turnn the BLUE KNOB gently in a clockwiise direction (by about 110 degrees) until you fee el a
clickk. Hold until you
y hear a be eep (about h half a secondd), then relea ase. Upon coompletion of an internal self-s
test, which take es approxim mately 3 se conds, the LCD will light up andd display “n never w/o cap!
c
recoording…” Th he LCD will th hen dim afteer a few seco onds to prese erve battery life, but the PASCAL is still
activve and awaitting data. You Y have 12 20 seconds following
f thee initial activaation of the LCD displayy to
acqu uire data. Do o not contactt the cornea prior to the LCD
L initially illuminating.
8) If you do not take e any data at this time, thhe device willl switch itself off after appproximately 120 secondss.

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USER MANUAL Proocedures

4.2. Disposab
bles and consumab
c bles

4.2.1. Fitting a SENSORCAP


1) To fiit a SENSORCAP over a SENSORTIP, rremove SENS SORTIP from Tip Carrier ((or retrieve SENSORTIP frrom
its co
ontainer if no ot yet installeed) by holdin ng the Tip Caarrier with on ne hand and pulling SENS SORTIP careffully
forwward (towardss patient sid de). You ma ay turn the Tip Carrier by 90° to eeither side to t facilitate this
t
proccess.
2) Makke sure that the t SENSORTIP is free off dust and particles.
p Cle
ean SENSORT IP (if necessary) by wip ping
genttly with a piecce of soft tiss sue that has been moiste ened with wa ater, or by ussing a jet of compressed
c air.
3) Peell the cover frrom the ApplliPack. Hold the SENSORTIP in one ha and and the AppliPack in n the other, and
a
insert the pressu ure sensor en nd of the SEN NSORTIP into the AppliPack. Make su re that you in nsert the end d of
the SENSORTIP collinear
c with the AppliPa ck, and do notn twist or ro ock the two ppieces agains st each otherr.
4) Push h the SENSORTIP into the e AppliPack q quite forcefullly, until it goes no furtherr. This will ca
ause the rub bber
ball inside the Ap ppliPack to push
p the cove er membrane into the concave shapee of the SENS SORTIP, and will
causse the mem mbrane to ad dhere to the e tip surfac
ce, eliminatin ng all wrinkkles and air--bubbles. Ke eep
SENS SORTIP pushed into AppliPack for 1 s econd, the pull p the SENSORTIP apart, without twisting.
5) Slow wly pull the SENSORTIP and a AppliPacck apart, witthout twisting or rockingg. Remember: “Straight In,
Straight Out!”.
6) Care efully verify proper
p fit of the
t SENSORC AP over the e SENSORTIP. For this pu rpose it is re ecommended d to
hold the end of thet SENSORTIP into the o ptical path of o the slit lamp, at an anggle toward the e incipient lig
ght,
for ggood visibiliity of the concave
c tip surface. No air bubbles should bbe visible underneath u the
SENS SORCAP, and its membrane should d fit snugly, without any y wrinkles, aagainst the curved conttact
surfaace of the SENSOR
E TIP. (FFig. 9; Fig. 100; Fig. 11)
Fig. 9 SENSORTIP with ap pplied SENSOR- Fig. 10 SEENSORTIP with applied
a SENSOR RCAP Fig . 11 SENSORTIP P with applied SENSOR-
CAP (correct fitt): membrane off (iincorrect fit): membrane
m of Caap does CAP (inco orrect fit): membrane of
CCap follows curvved tip surface n ot adhere to tip surface; stretch
hing Cap does not adhere to tiip sur-
ssmoothly; no follds or air pocketts olds can be see
fo en. face; air bubble fills entire
e space
ccan be seen. between tip and membran ne.

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.

It is usuallyy considered safe to use


e the same SENSORCAP on both eyees of the sam me patient. This
T
he patient and help avoid interruption in your patie
may help exxpedite yourr work with th ent session.

Using the SENSORTIP without


w SENSO ORCAPs will cause it to deteriorate
d quuickly, and may
m necessittate
expensive replacementt. Working w with unprotec
cted SENSOR RTIPs expose es patient to
o risk of cro
oss-
contamination from prev
vious patientts.

DISPOSAL L: Used SENS SORCAPs shoould be dispoosed of with other


o medicaal office wastte. All dispossals
should be carried
c out in accordance
e with applica
able local and
d national reegulations.

When placing the SENSORTIP back iinto its conta


ainer, make sure
s to take ooff the SENSO
ORCAP. Leavving
a SENSORCAP on the SENSORTIP m ay cause da amage to thee SENSORTIPP when trying g to remove the
SENSORCAP P after storage. The SEN
NSORCAP ma ay tear, leav
ving difficult to remove residues
r on the
surface of the SENSORTIP.

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USER MANUAL Procedures

4.2.2. Replacing the Battery


1) Hold the PASCAL Main Unit in one hand. With the other hand, compress the two holding clips of the
installed Battery Pack and remove it.
2) Insert a new Battery Pack, making sure it snaps into place and will not fall out when tilting the device.
3) Dispose of the used Battery Pack according to local requirements for recycling of waste.

Do not attempt to recharge a disposable Battery Pack.


4.2.3. Replacing the SENSORTIP
1) To switch from one SENSORTIP to another, simply pull the one out and insert the other one. The
individual factory-set calibration value of each SENSORTIP is stored in the SENSORTIP’s memory chip.
Therefore, PASCAL will measure correctly with each SENSORTIP used, without any calibration
adjustment required.
2) Before use, any SENSORTIP should be carefully inspected under the microscope for any damage or
contamination. Clean the tip if necessary, following the instructions provided in section 3.3. If you are
unsure about your tip’s integrity, do not use it. You may send it to a PASCAL Service Center for
inspection if in doubt, accompanied by a report of your observations.

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USER MANUAL Proocedures

4.3. Preparations for


f taking m
measurem
ments
Once PAASCAL has been set up p on your sllit lamp as described
d in section 4.1 , you are re
eady to use the
device aafter fitting a SENSORCAP over the e SENSORTIP, without any
a further preparationss, similar to
o a
conventiional Goldma ann applanattion tonometter:
1) Makke sure PASC CAL is mounted and prop perly aligned on the slit la amp.
2) Set illumination on slit lamp to intermed diate, using white
w light, to
o allow easyy viewing of the SENSOR RTIP
/corn
nea interfacee. Avoid unc comfortably b bright illumina
ation for patient comfort.
3) Insta
all a SENSORCAP Disposa able Tip Cove er, as per the instructions s in section 44.2.1.
4) Applly a drop of anesthetic
a to patient’s eyye (or both eyyes). No addition of Fluorrescein is req quired.
5) Bring
g the patientt into proper, comfortable e position for slit lamp inspection. Askk the patient to cooperate e by
holding eye wide e open and byb looking strraight ahead (The fixation n light availaable on some
e slit lamps may
m
be a useful aid. Also,
A keepingg the room li ghts on will help
h with thee patient’s fixxation).
6) Procceed with secction 4.4 to ta
ake an IOP m measuremen nt.

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USER MANUAL Proocedures

4.4. Takking measu


urements
At this poiint, if no fresh SENSORCAAP is in place
e protecting the
t SENSORT IP from direc ct eye contacct,
do not prooceed. Install a new SEN NSORCAP Dis sposable Tipp Cover first,, as per the instructions in
section 4.22.1.
7) Have e the patientt blink a few times and th hen, looking from the side, align the eend of the SENSORTIP clo ose
to th
he apex of the e patient’s co
ornea.
8) Swittch PASCAL unit on by turning
t BLUEE KNOB gently in clockwis se direction (by about 10 0 degrees) until
u
you feel a click; then
t release the knob. T he message e "Please wait. System Teest" will appe ear on the LC
CD.
Upon completion n of the internal self-testt, which take
es approxima ately 3 secoonds, the LCD will displa ay a
remiinder messa age "never w/ow Cap!". T The second d line of thee LCD displaay will read d "recording……",
indiccating that the device is now
n active an nd ready to record
r data.
9) Now w, looking thrrough the lefft ocular, carrefully advannce the slit la
amp until thee surface of the SENSOR RTIP
toucches the corn nea. Continue advancing g until the CANTILEVER
A he PASCAL will
is in an uprightt position. Th
soun nd an alert if the CANTILEVVER comes ttoo close to thet end of itss travel rangee. (Fig. 12)

Fig. 12 Motion of PASCAL CANTILEVER and SENSORTIP:

1 Before SEN
NSORTIP touches s eye, or if patieent moves away
y from the slit
3
lamp, CANT
TILEVER (red) tilts forward.

2 2 As PASCAL moves toward ds patient, CANTTILEVER (green) will be pushed


back vertica al and the conta
act surface will m
move slightly up
pwards due to th
he
circular trajectory of the SENSOR
E TIP.
1
3 If the PASC
CAL is advanced d too far, CANTI LEVER (pink) will tilt backward,
and the end
d-of-range alert will sound (pers
rsistent, repetitiv
ve beeps).
Note: Cantile
ever will be in optimum (green) possition for measure
ements when circuular
a reaches its highest position as seeen through the left ocular of the slit
contact area
lamp.

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USER MANUAL Proocedures

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)

14) Makke a note of the


t values being
b displayyed. Display will switch off
o after 60 seeconds and the system will
be re
eady for the next measurrement.
Poor Qualityy score (Q = 4 or
o 5) will be exttra warned by means
m of a special audio feedbback once the interrupt has be
een
detected andd of a LCD disp
play blinking for 10 seconds.

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.

PASCAL WIRELESS tonometers equipped fo or wireless communicatio


c on (optional)) will send th
he
result to a printer or PC
P if an activvated compa
atible device is found annd if this option is enable
ed.

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USER MANUAL Procedures

For details see section 5.3.

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.

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USER MANUAL Operating Instructions

5. PASCAL Operating Instructions


5.1. Basic Procedures
5.1.1. The BLUE KNOB
PASCAL is operated by means of a single control: the “BLUE KNOB”. Located on the lower right-hand side of
the device (as seen from the operator’s side), the BLUE KNOB is activated by turning the knob slightly in a
clockwise direction. After an approximately 10° turn, you will feel a “click”, which is a sensory feedback telling
you the switch behind the knob has been activated.
The BLUE KNOB responds to “short clicks” and to “long clicks”. Short clicks are performed by holding the knob
in the activated position for less than 1.5 seconds and long clicks are performed by holding the knob in the
activated position for longer than 1.5 seconds before releasing it.
A single short click will activate the PASCAL to initiate a measurement. Once the message “never w/o cap!
Recording…” is displayed on the LCD, you have 120 seconds to perform a measurement. If no incoming
data are being detected within that period, the device will shut itself off to preserve battery power. During the
shut down procedure, which takes 2 seconds, the PASCAL LCD will display the “powering down” message.
If the PASCAL is detecting data points different from zero pressure, it will continue recording these data to
memory until pressure readings drop to zero, indicating that the SENSORTIP is no longer in contact with the
patient’s cornea, or until memory is full (approx. 2 minutes).
Short clicks and long clicks of the BLUE KNOB are discussed further in section 5.2.

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USER MANUAL Operating Instructions

5.1.2. The Interrupt Maneuver


PASCAL’s built-in software is capable of computing the correct IOP and OPA values from the pressure curve
recorded in memory. For this routine to function properly, PASCAL must know the exact position of the zero
pressure baseline. This is determined by the software immediately after the user terminates the
measurement by pulling the SENSORTIP away from the patient’s cornea during the Interrupt Maneuver.
During a measurement, the software continuously monitors the incoming data, looking for a sequence of
data points that will match the characteristic pattern of a correctly performed Interrupt Maneuver. Such an
Interrupt Pattern will occur when the operator swiftly pulls the SENSORTIP away from the cornea by retracting
the slit lamp. If the pressure signal intermittently drops for other reasons (e.g. because of patient’s
movements or blinking, or due to the Contact Zone moving temporarily off-center), no Interrupt will be
recognized and the PASCAL will continue taking data (even though the sound may disappear for a short
moment).
When a successful Interrupt Pattern is detected, the program will terminate the current measurement and
start computation of the results. This is signaled to the operator by two short beeps. If you do not hear the
two short beeps when you retract the slit lamp, the software did not recognize a satisfactory Interrupt Pattern
and the measurement must be repeated.

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USER MANUAL Operating Instructions

5.2. Other operations


5.2.1. Adjusting PASCAL user settings
Several instrument settings may be adjusted by the user to suit individual preferences. User settings are
accessed while the PASCAL is active (i.e. is in recording mode and the LCD is active) by a “long click”
(holding the BLUE KNOB in the activated position for approximately 2 seconds). Repeated “long clicks” will
toggle through the User Settings Menu as per

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USER MANUAL Operating Instructions

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.

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Fig. 16: FW 4.01 Menu structure

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5.2.2. The Prior Results List


A list containing the results of the last 10 measurements may be accessed via the User Settings Menu as
described in section 5.2.1 oben. Results are presented in the order in which they were recorded, with the last
(most recent) result being shown first. For identification, the unique exam number associated with each
measurement is displayed, along with IOP, OPA, Q score, and estimated heart rate. (Fig. 17)

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

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.

5.3. Wireless Communication with a Printer or PC


This section only applies to "PASCAL WIRELESS" systems, which have been enabled for wireless data
communication. These systems are characterized by a part number beginning with 311.011.xxx.
For the wireless printing feature to function, a PASCAL wireless printer (p/n 311.660.001) must be available
and active, and must be initialized as described in section 5.3.1.
For the wireless pc transfer feature to function, an PASCAL interface program like the PASCAL DATA
WIZARDWIZARD or an EMR program, which is listening to the serial port, must be available and active. In
addition the “pc transfer” feature must be released by means of the PASCAL Downloader, a small accessory
program, and a unique activation keycode which may be purchased from the PASCAL website. If the option
is not activated, the option is not visible in the corresponding settings menu.
5.3.1. Getting started with the Printer
If the Printer was purchased together with a PASCAL WIRELESS unit, the system should already be set up
for printing. In this situation, it is sufficient to turn the printer on, making sure no other printer is active at the
same time. Perform a measurement with the PASCAL. A printout will automatically be generated within 20
seconds. If the printer does not react, it may need to be activated and the PASCAL-Printer link initialized as
detailed below.
5.3.2. Initializing the Printer
Make sure your PASCAL Tonometer is a wireless-enabled unit by checking the part number (311.111.xxx).
Place the printer in a location close to the PASCAL Tonometer (maximum distance: 10 meters or 30 feet).
Verify that paper is loaded, the printer receives power from its batteries, and it is switched on (blue LED
should be blinking slowly if printer is running on battery; permanently on if plugged into wall outlet). For the
initialization of the printer, make sure any other compatible printers within the transmission range are
switched off. For details on printer operation, please refer to manufacturer's manual.
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 “Printer search”
mode. The unit will now scan for any active PASCAL printers within its detection range. The ID of the first
printer found is stored in a temporary "printer address" memory location and a test printout will be performed
on it. If the information is printed on the intended printer, please acknowledge the LCD message “print
correct, confirm = click” to permanently store the printer address. Otherwise wait until the test printout comes
from the desired printer
Each time before PASCAL attempts to print, the status of the found printer will be interrogated. The status
message received from the printer includes error flags for “paper sensor failure”, "no paper", "wrong voltage",
and "high print head temperature" conditions. Corresponding error messages are sequentially displayed on
the PASCAL LCD. If an error shows, correct the condition, then, within 60 seconds, perform a single short
click of the BLUE KNOB to acknowledge.
5.3.3. Setting Print Parameters
Once a printer has been found and stored in the PASCAL's memory, one of three available printing formats
must be chosen from the Wireless Mode menu.

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 "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.

5.3.5. Initializing the PC


Make sure your PASCAL Tonometer is a wireless-enabled unit by checking the part number (311.111.xxx).
Ensure that your computer is close to the PASCAL Tonometer (maximum distance: 10 meters or 30 feet).
Verify that the Bluetooth USB Adapter is correctly plugged in (blue LED should be blinking), PASCAL
interface program (like PDW) is open and correctly set up. For details on the installation and setup of
PASCAL interface programs like EMR-software or PDW, please refer to the PASCAL EMR or PDW manual.
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 “PC search”
mode. If the option is not available, please refer to chapter 7.3.
The unit will now scan for any active computer within its detection range. The ID of the first computer found
is stored in a temporary "PC address" memory location and a hand shaking will be performed between the
PASCAL Tonometer and the PASCAL interface program (EMR-software or PDW) program. If the same ID is
displayed on the PASCAL interface program (like the PDW screen) and on the LCD, please acknowledge
the LCD message “ID …, confirm = click” to permanently store the computer address. Otherwise wait until
PDW ID is displayed on the desired computer.
Once a computer has been found and stored in the PASCAL's memory, the “PC transfer” mode must be
chosen from the Wireless Mode menu. To select this option, 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 “PC transfer” with repeated short clicks. Confirm your choice with a long click, and
then wait for your PASCAL to power down.

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.

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USER MANUAL Operating Instructions

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.

5.4. Reference information


5.4.1. BLUE KNOB Actions
User interaction with the PASCAL is by means of the BLUE KNOB. It permits switching between different
modes of operation, and is used for navigating through the User Settings menu. The various types of BLUE
KNOB actions are summarized in Table 1.
A “short click” has a duration of 200 µs (minimum) to 1.5 seconds (maximum). A “long click” has a duration of
1.5 seconds (minimum) to 5 seconds (maximum).

Table 1 Summary of BLUE KNOB Actions

Situation; Status BLUE KNOB Action Audio Result

all states brief touch none none

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 short click single beep start new measurement.


to take measurement

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 short click none start new measurement.


measurement is
terminated

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.

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USER MANUAL Operating Instructions

5.4.2. User Settings Menu


The parameters listed below may be adjusted by the user to personalize the operating environment of the
PASCAL Tonometer. Values may be adjusted by means of the BLUE KNOB as detailed in Table 1.
 Prior Results List (not an adjustable setting, but accessed in the User Settings Menu)
– The last 10 results (exam number, IOP, OPA, H, and Q).
 Volume
– Used for adjusting loudness of audio output.
– Value range / Format: "00" (mute) – "07" (maximum).
– Default setting: 04.
 Contrast
– Used for optimizing readability of the LCD display.
– Value range / Format: "01" (maximum.) – "08" (minimum.).
– Default setting: 02.
 Language
– Used for selecting desired dialog language.
– Value range / Format: "English", "Deutsch", "Français", "Italiano", "Español", Portugues".
– Default setting: English.
 Wireless mode (available only on PASCAL WIRELESS systems)
– Used for selecting the type of output desired.
– Value range / Format: "inactive", "print values", "print val/range", "print val/curve", “PC transfer1”
– Default setting: inactive.
 Wireless action (available only on PASCAL WIRELESS systems)
– Used mainly for setting up the printer or PC transmission mode
– The option “firmw. download” is used to update the operating firmware
– Value range / Format: "inactive", "print history", "search printer", "search PC1", “firmw. Download”
– Default setting: inactive.
 Performance Test
– Used for switching to Performance Test mode.
– Value range / Format: "disabled", "active".
– Default setting: disabled.
 CANTILEVER Test
– Used for switching to CANTILEVER Test mode.
– Value range / Format: "disabled", "active".
– Default setting: disabled.
 MANOMETER Mode
– Used for switching to Manometer mode.
– Value range / Format: "disabled", "active".
– Default setting: disabled.

5.4.3. Printer Reference Information


For full details, refer to printer manual.
 To switch the printer on:
– Push printer button (on top of transparent printer cover) for at least 1 second.
 To switch the printer off:
– Push printer button twice. LED will flash rapidly, then turn off.
 To activate printer setup mode:
– If printer is off, push printer button for at least 3 seconds; printer will print a test pattern.
– Push printer button for 1 second to modify parameters (see printer manual for details).
– Click on printer button to put printer into "on line" status.
 To change setup / activate parameters in setup mode:

1
May be not available if the option has not been installed (cf chapter 5.3)

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– To change a single parameter, click on printer button.


– To confirm a single parameter and move on to next parameter, push printer button for 1 second.
– When printer configuration is complete, printer will automatically be "on line".
 To replace printer batteries:
– Remove cover of battery compartment by unscrewing the 2 screws.
– Remove old batteries and insert 5 new AA rechargeable penlight batteries as shown on bottom of
battery compartment.
– Close battery compartment by tightening the fastening screws.
 To replace paper roll:
– Hold new paper roll with the end of the paper pointing towards you from the underside of the roll.
– Open printer lid. Place paper roll inside paper compartment.
– Pull paper end towards you and close lid.
5.4.4. Battery Charger Reference Information
The PASCAL battery charger base features a receptacle shaped to accommodate one rechargeable battery
pack. The battery pack is inserted into, and removed from, the charger base in the same fashion as on the
PASCAL Main Unit. Operating status of the charger base is monitored by means of two LEDs:
 Green LED at left: When lit, charger base is connected to power supply and is receiving correct voltage.
 LED at right: Red: charging. Green: charging complete.
When charging is complete, battery pack will receive a maintenance charge while left in the charger. Charger
will recognize type of battery pack inserted. If a disposable, non-rechargeable battery pack is inserted, no
charging will occur.

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USER MANUAL Care and Maintenance

6. Care and Maintenance


6.1. Periodic check of SENSORTIP
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. Any of these influences
may be the cause for slow degradation of performance due to small fissures in the silicone material in which
the pressure sensor is embedded. This may cause a SensorTip to generate readings that are noisy and
inaccurate. Degrading SensorTips can be difficult to notice in the early stages. The following provides
recommendations for periodical checking of your SensorTips which must be performed once a year.
6.1.1. Visual Inspection of SensorTips
A quick and simple visual inspection of your SensorTip can help you detect early signs of degradation. This
inspection is best performed by holding the SensorTip into the focal point of your slit lamp microscope, with
the contoured tip surface pointing towards you. Carefully inspect the rim of the circular cavity in which the
pressure sensor is embedded, moving the tip slightly back and forth to illuminate it at varying angles.
A perfect, fully functional tip exhibits an inner surface of the cylindrical cavity bore that appears bright white,
reflecting the color of the chip holding the sensor. See Figure A.
If the silicone material in the bore is partially detached from the walls of the cavity, parts of the cylindrical
surface will appear greenish, reflecting the color of the chip holding the sensor. See Figures B, C, D.

Fig. A Good Tip Fig B Deteriorating Tip

Fig. C Deteriorated Tip Fig D Deteriorated Tip


(late stage)

Insets show detached parts of silicone filling material marked in red.

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6.1.2. Appearance of Pressure Curves


Use the PASCAL Printer (311.660.001) to obtain printouts of your pressure curves, or inspect the pressure
curves using any PC interface program for the PASCAL. If your SensorTip is in good operating condition, it
will generate pressure curves with minimal noise and the typical, regular features as in Figure E.
Compromised SensorTips will generate noisy pressure curves that look increasingly irregular and will only
rarely display a Quality of 2 or better. Individual noisy curves may of course always occur if good patient
cooperation cannot be achieved. Examples of suspect curves are exhibited in Figures F and G.

Fig. E
Good Tip:
no visible noise

Fig. F
Bad Tip:
noisy curve

Fig. G
Bad Tip:
Irregular curve

6.1.3. Recommendations to avoid degradation


Follow the instructions in the User Manual, section 6.2, for handling and cleaning your SensorTips. Do not
clean the tip more often than necessary. Always use TipCovers. Do not keep TipCovers on the SensorTip for
extended periods of time. Avoid any vigorous movements when cleaning the Tip. Use soft tissue and water.
Never use alcohol on the SensorTip.

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6.2. System checks and calibrations


The PASCAL system performs a self-calibration each time the device is activated by a “short click” of the
BLUE KNOB, setting its baseline to the prevailing atmospheric pressure. Furthermore, the system performs a
self-test when activated, checking its settings and the proper functioning of electrical connections.
The user may perform functional tests if desired. The tests consist of two elements: a cantilever test,
verifying proper mechanical functioning of the CANTILEVER, and a manometric performance test, which
compares the pressure value detected by the SENSORTIP with that obtained from a reference. For the latter,
the PASCAL Test Kit (available as an option) is required. Users who do not wish to perform these functional
tests themselves may request their distributor or local service center to perform the tests at recommended
intervals.
6.2.1. Performance Test

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.

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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.

6.2.3. Manometer Mode


When PASCAL is in Manometer Mode, it will continuously display the manometric pressure, relative to
atmospheric pressure, detected by the pressure sensor. In this mode, the PASCAL may thus be tested
directly against a manometric standard.
6.2.4. Calibration of Main Unit and SensorTips
Calibration requires special equipment and can only be performed by an authorized service center. A
calibration procedure is only required if the Performance Test has indicated a calibration failure.

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.

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6.4. Maintenance and repairs


Only original parts supplied by SMT should be used with PASCAL. Using any non-SMT
parts will void any warranty and may cause improper functioning of the device.

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.

Do not attempt to modify or alter your PASCAL Tonometer.

(PASCAL WIRELESS systems only:) Changes or modifications not expressly approved by


the manufacturer could void the user's authority to operate the equipment.

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.

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USER MANUAL Troublesshooting

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..

Watching the Video DVD


D "Workinng with PASCCAL" (availab
ble from youur distributor)) may be use
eful
for identiifying and correcting ppossible pro
oblems associated withh operating the PASC CAL
Tonometeer.

7.1. Troubles
shooting guide
g
Observe
ed behavior Possible cause Action
n to take

Upon acctivating the BLUE Battery Pack misssing, or not fu


ully Insert Battery Pack and make surre it snaps into
o
KNOB, nothing happen ns inserted. place.
Dis
scharged batte
ery Replace battery
Clic
ck too short Startin
ng up the devi ce’s microprocessor takes a
short moment.
m Holdd the Knob in the
t “ON” posittion
until you hear a beeep.
LCD baccklight does not stay Backlighting is o nly briefly actiive (None
e. This is by deesign, to save battery life).
on at activation
a d when result is
and
displayed
Can’t he
ear audio feed
dback Volume may be set too low, or Accesss the User Seettings Menu, choose “Volum me”,
when reecording data. ma
ay be off. and se
et a higher nummber. If unsuc
ccessful, conta
act
your distributor.
d
Eyee may not be touching the Move the PASCAL, by using the slit lamp's joysstick,
essure sensor ; SENSORTIP not
pre n in orde
er to have thee pressure sennsor centered on
alig
gned correctlyy on eye. the co
ontact area, ass depicted in Fig.
F 13.
Ma
aybe a wrinkle or air-bubble in Reapp
ply SENSORCAAP.
SENSORCAP.
SensorTip may b be touching Verify positioning off SensorTip byy looking fromm the
pattient's eyelid o
or eyelashes. side; instruct patientt to open eyes
s, or assist by
holding lid open; re--start procedure.
IOP
P less than 5m
mmHg Proceed and take m measurement normally (device
cord data norm
will rec mally, only sound will not
activate if IOP less tthan 5 mmHg)
PA
ASCAL not turn
ned on. Remove SensorTip from eye, acttivate PASCAL L,
wait fo
or LCD to illum
minate before contacting the
e eye
with th
he SensorTip.
PA
ASCAL activate
ed after the Remove SensorTip from eye, acttivate PASCAL L
SensorTip was a
applied to the eye. again, wait for LCD to illuminate before
b contactting
the ey
ye with the SennsorTip.
Sound iss too loud whe
en Volume set too h
high. Accesss the User Seettings Menu, choose “Volum me”,
recordin
ng data. and se
et a lower num
mber. Set to zeero to turn sou
und
off.
Sound iss interrupted when
w CANTILEVER has not traveled fa
ar Move slit lamp slighhtly forward (to
owards patientt).
recordin
ng data. eno
ough.
Intermitttent beeps wh
hile CANTILEVER has ttraveled too fa
ar Move slit lamp slighhtly back (towa
ards you; awayy
recordin
ng. (yo
ou are too closse to eye). from patient)
p
Text on LCD is hard to
t read. LCD contrast ma
ay be set too low. Accesss the User Seettings Menu, choose “Contrrast”,
and se
et a lower num
mber. If unsuccessful, conta
act
your distributor.
d
After liftiing off the eye
e, Sofftware did nott recognize a valid
v Contact eye again aand repeat me easurement. Lift
L off
recordin ng does not sto op. (No Inte
errupt Maneuvver. the ey
ye swiftly usingg slit lamp’s jo
oystick.
double b beep and no result
r
display o on LCD)
PAASCAL may be e set to recordd Contact SMT Servicce to reset PA
ASCAL’s intern
nal
sevveral Interruptts before stopp ping setting
gs.
(no
on-standard se etting for clinic
cal
stu
udy use only).

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Observed behavior Possible cause Action 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).

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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..

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7.2.2. Printer status mess


sages (on P
PASCAL Main Unit):

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.

7.2.3. PC stattus message


es (on PASC
CAL Main Unit):

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

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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.

7.2.4. Printer sta


atus messag
ges (on prin
nter):

Blue LED alwayys off Printer


P is off. Depress PPrinter Button for
f at least 1
second, unntil LED turns on.
Blue LED alwayys on Printer
P is on; cconnected to wall
w outlet;
batteries
b are reecharging; no error
detected.
d
Blue LE ery slowly Printer
ED blinking ve P is on; ru
unning on battteries; no
error
e detected..
Blue L
LED blinking
g slowly "P
Paper roll emp
pty" message. Insert new roll of therma
al paper.

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

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7.2.5. PC status messages (from USB Adapter):

Adapter is disconnected. Plug the USB Adapter ("Dongle")


into the USB port.

Adapter connected.

A device is connected to the


adapter.

A device is connected to
COM5 of the USB adapter.

The corresponding COM port 1) Ensure PASCAL is switched


is currently not available. on.
2) Retry to reopen the COM port.

More detailed information can be found in the specific user manual for the PASCAL DATA WIZARD.

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7.3. Frequently asked questions


Q: To what position on the pressure curve does the IOP shown correspond?
A: The IOP value displayed corresponds to the average of a few minimum points on the ocular pulse
curve. This value might be termed “diastolic IOP” as it corresponds to the minimum pressure to which
internal structures are subjected during the cardiac cycle.
Q: What is the relevance of the OPA value displayed?
A: OPA represents the mean difference between minimum and maximum points on the ocular pulse curve,
i.e. the range of pressure change during the cardiac cycle. When the OPA value is added to the IOP
value, the maximum intra-ocular pressure during the cardiac cycle, i.e. the “systolic IOP,” is obtained.
Q: Should I correct my PASCAL IOP readings for corneal thickness; and which correction nomogram
should I use?
A: PASCAL IOP measurements are not influenced by corneal thickness and other variations in corneal
properties. Therefore, no correction should be applied to your readings.
Q: How can I check if the CANTILEVER is in proper position while measuring?
A: The CANTILEVER is in correct position if you hear an uninterrupted oscillating sound synchronous with
the patient’s heartbeat. If the CANTILEVER excursion is too small, the oscillating sound will be broken and
discontinuous. (This is the most common error in user technique, particularly if the user has been
trained to take Goldmann applanation tonometry readings where minimal corneal contact pressure is
preferable.) If the CANTILEVER excursion is too great, you will hear alerting beeps.
Q: The sound I am hearing is interrupted or "broken up".
A: You may be just barely touching the patient's eye, without sufficiently deflecting the CANTILEVER (see
also question above).
Q: How long should I stay on the eye to take data?
A: You will hear the three tone melody that tells you when the desired quality is reached. This can be set
with the Q-indicator accourding to Figure 16. The PASCAL software routine requires a minimum of three
full, undisturbed heartbeat cycles for computing IOP and OPA reliably.
Q: Can I use PASCAL without disposable SENSORCAPS?
A: Using SENSORTIPS without SENSORCAPS will cause the SENSORTIPS to deteriorate quickly, causing
expensive replacement. Working with an unprotected SENSORTIP exposes the patient to risk of cross-
contamination from previous patients.
Q: Is it OK to clean and re-use SENSORCAPS?
A: We have NOT TESTED, and we are not planning to test, the viability of SENSORCAPS after attempted
cleaning with alcohol or any other means. We strictly discourage any such practice. We must assume
that using alcohol to "clean" SENSORCAPS after use is NOT SAFE. Traces of alcohol remaining in the
membrane material may in fact cause damage to the next patient's epithelium (epitheliolysis). Doctors
planning to re-use SENSORCAPS will do so AT THEIR OWN RISK, irrespective of how they attempt to
"clean" their used SENSORCAPS.
Q: May the SENSORTIP be sterilized?
A: Circuitry within the SENSORTIP does not tolerate autoclave sterilization. Attempts to sterilize the
SENSORTIP will cause irreversible damage.
Q: How should I protect my SENSORTIP when the PASCAL is not in use?
A: In-between measurements, and overnight, keep the SENSORTIP on the tonometer. For protection over
prolonged periods of time, it is recommended to remove the SENSORTIP from the PASCAL unit, remove
any SENSORCAP, and store the SENSORTIP in its storage container.
Q: May I clean SENSORTIPs by immersing in Pantasept or a similar disinfectant?
A: Exposure of electrical contacts, circuitry, and tip surface to disinfecting preparations or to bleach may
cause irreversible damage and/or malfunction.

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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.

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7.4. Tips and Tricks


7.4.1. Optimizing patient cooperation
 Drop anesthetic in both eyes, to reduce patient’s blinking urge.
 Keep the room lights on so the visual input from the opposite eye will distract the patient from the
approach of the SENSORTIP towards the measured eye. Having the room lights on also helps with
the patient’s fixation.
 Suggest to the patient to fixate on fixating light (installed on some slit lamps), or on your earlobe,
or on an object across the room. A steady eye will greatly improve the quality of the readings.
 Encourage the patient to listen to the sound generated by his/her heartbeat, and to try and make it
sound “nice and regular”.
 Avoid staying on the eye with the PASCAL device longer than necessary. Eventually patient will
start blinking, and it will become increasingly difficult to terminate the measurement in an orderly
fashion to achieve a high-quality Interrupt Maneuver. Three smooth continuous waveforms of
sound (heartbeats) is minimal, six waveforms is optimal, more than ten waveforms is excessive.
 To avoid touching the patient's eyelashes (which will cause patient to blink), try approaching the
eye with the SensorTip positioned slightly below the apex of the cornea. When moving forward
after making the first contact with the cornea, the contact surface of the SensorTip will move up
due to the movement arc of the cantilever, and with some minor corrections you will easily reach a
properly centered position on the cornea for your measurement.
7.4.2. Working with SENSORCAP protective tip covers
 Never use the same SENSORCAP on more than one patient. Attempting to wipe the SENSORCAP
may damage it and may cause instrument malfunction.
 It is usually considered safe to use the same SENSORCAP on both eyes of the same patient. This
may help expedite your work with the patient and help avoid interruption in your patient session.
 If you are planning to leave your PASCAL unused for a prolonged period of time (i.e. more than 1-
2 days), it is recommended to remove the last SENSORCAP from the SENSORTIP. If left on too long,
SENSORCAPs may stick to the SENSORTIP surface, making them difficult to remove.
7.4.3. Working with SensorTips
 To insert or remove a SENSORTIP while PASCAL is mounted on the slit lamp, the tip carrier may
be rotated 90° to either side. For correct operation, make sure the tip carrier is properly re-aligned
with the microscope’s optical axis after inserting a SENSORTIP.
 To clean your SENSORTIPs, use a soft tissue (e.g. Kleenex) soaked in water. If necessary, a few
drops of clear household soap solution may be added. However, use alcohol sparingly and not
too often. Wipe contact surface with a rotating motion. Alternatively, compressed clean air (e.g.
"Dust-Off") may be used to remove any particles that may stick to the SENSORTIP surface. Avoid
using any sharp or hard objects when cleaning the SENSORTIP.
 Should a SENSORTIP become contaminated, clean it immediately after use to prevent any deposits
from drying on its surface. If you detect any salt crystals (e.g. dried tear fluid) adhering to the tip,
rinse thoroughly with water to dissolve any residue. Salt crystals rubbed into the tip may severely
damage the tip.
 Do not soak or submerge SENSORTIPs — the electrical contacts at the rear may get damaged.

7.4.4. Working with the wireless printer


 It is highly recommended to leave the printer always plugged in. This will help to avoid problems
arising from a broken connection between PASCAL and its associated printer.
 If a “Printer problem” (cf 7.2.2) arises, which can not be fixed within 60 seconds, it is suggested to
confirm the printer status messages until the results are displayed on the LCD again. This will
allow the user to record the reult manually.

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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.

D Fig. 19 Contour Tonometer. Schematic representation of


cylindrical, contoured tip in contact with cornea
Tip (“Contour Match”).
Pressure
F sensor RT
RC Radius of Cornea
RT Curvature Radius of Tonometer Tip
F appositional force
FP internal force generated by IOP
FP d diameter of contact area AC
P intra-ocular pressure (IOP)
d Rc
FP FP Cornea
P

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

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USER MANUAL Appendix

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.

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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.

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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.

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8.2. How does PASCAL compute IOP and OPA?


During a measurement, the pressure signal detected by the pressure sensor built into the SENSORTIP is
digitized 100 times per second in real-time and stored in the unit’s memory. Also, the signal is continuously
converted into an audio signal to provide audio feedback to the user. The processing unit continuously
monitors the signal level. When the level drops to zero after the tonometer is retracted from the eye, the
processor will compute the zero level baseline signal and use this as a reference value for the subsequent
calculation of IOP. At this point, data acquisition will stop and a double beep will sound.
As a next step, the system software will perform the RangeFinder routine, analyzing the entire pulse curve
recorded and looking for sections than contain the characteristic oscillation typical for an ocular pulse curve.
Sections containing excessive noise or glitches, or any other irregularities, will be ignored. Sections
containing valid data are then compared and ranked according to their quality. The section ranking highest is
then chosen as the range to be used for computational analysis.
The software finds the evenly spaced maxima and minima and generates a list containing their positions and
intensities. The average of all minima found is computed and posted as IOP. The average of all differences
between maxima and minima is computed and posted as OPA (Ocular Pulse Amplitude).
The reliability of the result thus obtained is assessed according to several criteria, and posted as a quality
rating, or "Q score". Q = 1 denotes an optimum quality result; Q = 4 or 5 denotes an increasingly
questionable result which should be taken with caution. It may be advisable to repeat a measurement if Q =
4 or 5.
If the software cannot find a valid range for performing the computation, or if the zero level baseline cannot
be determined, no result will be posted.
Posted results for IOP, OPA, and Q are displayed on the built-in LCD, and written into a results list for later
retrieval.

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8.2.1. The Q score


You can set a desired Quality in the menu under Q-indicator (Figure 16). The Q indicator gives you a
feedback in form of a 3-tone melody when the set Quality is reached. Try to achieve a Quality of 1 or 2 and
set the Q-indicator accordingly.
Each time PASCAL computes and displays an IOP measurement result, the Quality of the result is assessed
and a "Q score" is computed and displayed. Q = 1 stands for optimum quality; Q = 5 represents poor quality.
A good Q score (Q = 3 or less) indicates that the result was computed from high quality data and therefore
can be assumed to be reliable. If the Q score is poor (Q = 4 or 5), a possibility exists that the algorithms used
for extracting minima and maxima from the ocular pulse pressure curve have been misled by artifacts in the
data, possibly producing an erroneous result.
To compute the Q score, the data points collected are examined for characteristics such as noise level,
spikes (singularities), drift, and continuity. The amount of data available (i.e. the number of diastoles and
systoles (minima and maxima) found is also taken into consideration. The Q score obtained is a weighted
composite of these components.
When a result with a Q score of 4 or 5 is obtained, the result may correspond to the correct IOP/OPA but it
may also be in error as the computation routines may not be able to deal with the irregularities in the data
correctly. Hence it is strongly advisable to discard any results with a Q higher than 3, and to repeat the
measurement. Poor Quality score (Q = 4 or 5) will be extra warned by means of a special audio feedback
once the interrupt has been detected and of a LCD display blinking for 10 seconds.
To obtain better (lower) Q scores, try the following:
 Obtain better patient cooperation, by advising patient to relax, keep the eye open and look straight
ahead.
 Obtain a longer stream of data by keeping the SENSORTIP centered on the contact zone for a few
seconds longer. While a result can be computed from as few as three pulse cycles, obtaining 5 to 6
pulse cycles will tend to furnish a more reliable result with a lower (better) Q score.
Occasionally, patients with cardiac arrhythmia are encountered. Depending on the specific characteristics
and frequency of occurrence of the arrhythmia, such pulse curves can be a challenge for PASCAL's
IOP/OPA algorithm. Such situations may easily be detected, and an IOP estimate obtained visually, by
inspecting the actual pulse curve printout (available only on PASCAL WIRELESS systems equipped with a
printer).

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8.3. PASCAL Firmware Structure


The firmware (software controlling the internal microprocessor) of the PASCAL Tonometer operates in two
basic modes (additional remote-controlled modes used for servicing are not considered here). The interplay
between the two modes is depicted in Fig. 23.
Recording Mode (or “Active Mode”) is automatically activated when PASCAL is switched on with a short
click of the BLUE KNOB. In this mode, the PASCAL takes data and detects when the user ends the
measurement (i.e. pulls the tonometer away from the patient’s eye). It analyzes the recorded data and
computes and displays the result of the measurement. When finished, the PASCAL automatically shuts
down. The entire process proceeds automatically. The only user input recognized by the software while in
Recording Mode is the command to access the User Settings Menu (executed by performing a “long click”).
In Settings Mode, the user may view and, if desired, modify certain basic instrument settings within the User
Settings Menu, or view a list of results from preceding measurements. In User Settings Menu Mode, the
user may view, and modify, certain basic instrument settings, or view a list of results from preceding
measurements.

Fig. 23 PASCAL Firmware Structure: Recording Mode and Settings Mode

initialize

beep SENSORCAP
Reminder

Recording Mode

Recording
Message

Stop & restart Short Click


YES
NO

Long Click Settings Mode


YES
NO

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

*) for details on Settings Mode see

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Fig. 16

8.4. Technical Specifications


8.4.1. Tonometer System
Part Number: Standard PASCAL System: 311.001.001 or 311.001.002
PASCAL WIRELESS 311.011.001 or 311.011.002
System:
Description: Dynamic Contour Tonometer
Device Type: Contact Tonometer
®
Trade Name: PASCAL
Safety design standards: EN 60601-1:1990 + A1:1993 + A2:1995
Classification: Class IIa Medical Device (MDD, 93/42/EWG)
Registration (Europe): 0297 (CE-marked)
Registration (USA): FDA 510(k) premarket notification K#032967
®
FCC labeling PASCAL Model No. 311.011.001 / 002
(PASCAL WIRELESS systems only): Contains FCC ID: POOWML-C10XX
IC: 5508A-PASCAL
IC labeling (Canada)
(PASCAL WIRELESS systems only): (The term "IC" before the certification / Registration number only signifies that
the Industry Canada technical specifications were met.)
IOP recording range: 5 to 80 mmHg
Minimum OPA detection limit: 0.5 mmHg
A/D converter sampling rate: 100Hz at 12 bit dynamic range
Resolution: ± 0.10 mmHg
Precision: ± 2% or ± 0.2 mmHg, whichever is larger
Maximum recording time: 120 sec
Battery voltage range: 2.0 - 3.5 VDC
Transmission range Up to 10 meters (30 feet) inside same room
(PASCAL WIRELESS systems only):
Dimensions: 170 mm (H) x 88 mm (W) x 40 mm (D)
Contact diameter of SENSORTIP: 7.0 mm
Curvature radius of SENSORTIP: 10.5 mm
Weight: 210 g
Shipping Weight: 2.400 kg
Main Unit Microprocessor: Mitsubishi M30626 FHPFP.
Memory: 384kB Flash internal, 32kB SRAM internal, 512kB SRAM external,
EEPROM Microwire 16kB external
Ambient operating temperature: +10°C to +45°C (50 to 115°F)
Storage temperature: 0°C to +55°C (30 to 130°F)
Ambient operating atmospheric pressure: 800 hPa to 1060 hPa
Storage atmospheric pressure: 700 hPa to 1060 hPa
Operating humidity: 20 – 75 % relative humidity
Storage humidity: 0 – 95 % relative humidity
Manufacturer: SMT Swiss Microtechnology AG
Allmendstrasse 11, CH-2562 Port (Switzerland)
phone: +41 32 332 7080 e-mail: vision@smtag.ch
website: www.smtag.ch

8.4.2. Printer Accessory


Part Number: 311.660.001
Model Number: DPT-100-BT
Description: Thermal printer, portable, battery operated. Equipped with a
rechargeable battery pack and power supply
Paper: Thermal printer paper rolls, 58 mm wide

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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

8.4.3. Rechargeable Battery Kit


Part Number: 311.761.001
Description: Electronic battery charger
Power Supply Voltage: 100 – 240V AC ±10% 50/60Hz primary;
12V DC ±10%, 800 mA secondary
Outlet plug adapters: Swiss, Euro, USA, UK, Australia
Dimensions, Weight:: 7.2 X 5.9 X 4.4 cm (with battery pack); 520 g
Temperature: 0 – 25° C (32 – 77º F)
Manufacturer: Hy-Line Power Components AG
Gründenstrasse 62, CH-8247 Flurlingen, Switzerland
Phone: +41 52 647 42 01
www.hy-line.ch

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8.4.4. System Components


Name Description

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

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8.4.5. Manufacturer’s EMC Declaration


Changes or modifications to this system not expressly approved by the manufacturer may result in increased
emissions or decreased immunity performance of the equipment or system and could cause EMC issues
with this or other equipment. This system is designed and tested to comply with applicable regulations
regarding EMC and shall be installed and put into service according to the EMC information stated as
follows.
WARNING
Use of portable phones or other radio frequency (RF) emitting equipment near the system may cause
unexpected or adverse operation.
WARNING
The equipment or system shall not be used adjacent to, or stacked with, other equipment. If adjacent or
stacked use is necessary, the equipment or system shall be tested to verify normal operation in the
configuration in which it is being used.
Compliant Cables and Accessories
The table below lists cables, transducers, and other applicable accessories for which the manufacturer
claims EMC compliance.
NOTE: Any supplied accessories that do not affect EMC compliance are not listed.

Part No. Type Description Length max.


311.660.001 PASCAL Printer Wireless printer, battery operated n/a
311.761.001 Rechargeable Battery Kit Battery Charger Kit (110/220V), with two rechargeable batteries n/a
(to be used in lieu of disposable batteries included with System).

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.

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Table 201:

Guidance and manufacturer’s declaration – electromagnetic emissions


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.

Emissions test Compliance Electromagnetic environment - guidance


RF emissions Group 1 The EQUIPMENT uses RF energy only for its
CISPR 11 internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions Class B The EQUIPMENT is suitable for use in all
CISPR 11 establishments, including domestic establishments
and those directly connected to the public low-
Harmonic emissions Not applicable voltage power supply network that supplies
buildings used for domestic purposes.
IEC 61000-3-2

Voltage fluctuations/flicker emissions Not applicable


IEC 61000-3-3

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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.

Immunity tests IEC 60601 Compliance level Electromagnetic environment - guidance


Test level
Electrostatic discharge ± 6 kV ± 6 kV Floors should be wood, concrete or ceramic tile. If
(ESD) Contact discharge Contact discharge floors are covered with synthetic material, the
relative humidity should be at least 30 %.
IEC 61000-4-2
± 8 kV ± 8 kV
Air discharge Air discharge
Electrical fast Not applicable Not applicable
transient/burst
IEC 61000-4-4

Surge Not applicable Not applicable


IEC 61000-4-5

Voltage dips, short Not applicable Not applicable


interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11

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.

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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.

Immunity tests IEC 60601 Compliance level Electromagnetic environment - guidance


Test level
Portable and mobile RF communications equipment
should be used no closer to any part of the
EQUIPMENT, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance:
Conducted RF Not applicable Not applicable
d  1.2 P
IEC 61000-4-6
Radiated RF 3 V/m 3 V/m
d  1.2 P 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5 GHz

d  2.3 P 800 MHz to 2,5 GHz


where P is the maximum output power rating in the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
a
determined by an electromagnetic site survey, should
be less than the compliance level in each frequency
b
range.
Interference may occur in the vicinity of equipment
marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a
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.

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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.

Separation distance according to frequency of transmitter


Rated maximum output m
power of transmitter (P)
W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d  1.2 P d  1.2 P d  2.3 P

0.01 0.12 0.12 0.23


0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the higher frequency range applies.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.

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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

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8.5. Accessories and Consumables


Name description

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.

8.6. Warranty Information


PASCAL is marketed for SMT AG by Ziemer Ophthalmic Systems AG. PASCAL is covered by Ziemer
Ophthalmic Systems' limited warranty as per its published Limited Warranty Terms applicable at the time of
purchase. The detailed Limited Warranty Terms are available from Ziemer Ophthalmic Systems upon
request.
In summary, Ziemer Ophthalmic Systems AG guarantees the PASCAL Dynamic Contour Tonometer for 12 months from the date of
purchase to be free of defects in parts and workmanship. This warranty is valid only to the original purchaser of the device, and only if
all repairs, maintenance and adjustments were made by SMT or by a certified Service Center.

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8.7. Service and Support Information


For any support, service, or maintenance, please contact the Distributor from whom you have purchased
your PASCAL Tonometer, or a SMT-authorized Service Center. A list of contacts for specific support
situations is available from SMT’s website at www.pascal-tonometer.com .
Should the PASCAL tonometer and / or an accessory fail to operate as expected, please proceed following
the steps outlined in section 6.4.
For all questions and problems relating to your PASCAL Dynamic Contour Tonometer, you may also contact
the Central Customer Support facility of Ziemer Ophthalmic Systems Group:
e-mail: customer.service@ziemer-ophthalmics.com
website: www.ziemer-ophthalmics.com
Phone: +41 32 332 7050
Mail Address: Ziemer Ophthalmic Systems Group AG
Allmendstrasse 11
CH-2562 Port (Switzerland)

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