6100-50-0005-04 pascal user manual en

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: [email protected] web: www.pascal-tonometer.com 0297

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

USER MANUAL

6100-50-0005-04 PASCAL UserManual_en 27.09.2012 Doc#: 6100-50-0005-04 - 2 - © 2012 SMT AG, Switzerland

TABLE OF CONTENTS

1. INTRODUCTION .................................................... 4 1.1. PASCAL® Systems covered in this Manual ......... 4 1.2. Indications for use ............................................... 4 1.3. General description ............................................. 4 1.4. How to use this manual ....................................... 5

1.4.1. Explanation of symbols ............................................. 6 2. SYSTEM COMPONENTS ...................................... 7 2.1. Main Unit ............................................................. 7 2.2. PASCAL Firmware .............................................. 7 2.3. Accessories and Consumables ........................... 8

2.3.1. PASCAL Wireless Printer ......................................... 8 2.3.2. Adapter Kit for Haag-Streit-type Slit Lamps .............. 8 2.3.3. Swing Arms for various types of slit lamps ............... 8 2.3.4. Test Kit ...................................................................... 8 2.3.5. Additional SENSORTIPS ............................................. 8 2.3.6. SENSORCAP™ Disposable Tip Covers ...................... 9 2.3.7. Non-rechargeable Battery Packs .............................. 9 2.3.8. Rechargeable Battery Packs .................................... 9

2.4. Additional required material (not supplied) .......... 9 3. SAFETY INSTRUCTIONS .................................... 10 3.1. Intended Use ..................................................... 10 3.2. Patient Safety .................................................... 10 3.3. Operational Safety............................................. 10 4. PROCEDURES .................................................... 12 4.1. System set-up ................................................... 12

4.1.1. Attaching PASCAL to your slit lamp ....................... 12 4.1.2. Readying PASCAL for taking measurements ....... 13

4.2. Disposables and consumables .......................... 14 4.2.1. Fitting a SENSORCAP ............................................. 14 4.2.2. Replacing the Battery.............................................. 15 4.2.3. Replacing the SENSORTIP ....................................... 15

4.3. Preparations for taking measurements ............ 16 4.4. Taking measurements ..................................... 17 5. PASCAL OPERATING INSTRUCTIONS ............. 20 5.1. Basic Procedures .............................................. 20

5.1.1. The BLUE KNOB ....................................................... 20 5.1.2. The Interrupt Maneuver .......................................... 21

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

6.2.3. Manometer Mode ................................................... 33 6.2.4. Calibration of Main Unit and SensorTips ................ 33

6.3. Cleaning ............................................................ 33 6.4. Maintenance and repairs ................................... 34 6.5. Disposal ............................................................ 34 7. TROUBLESHOOTING ......................................... 35 7.1. Troubleshooting guide ....................................... 35 7.2. Error Messages and Status Messages .............. 37

7.2.1. PASCAL Main Unit ................................................. 37 7.2.2. Printer status messages (on PASCAL Main Unit): . 38 7.2.3. PC status messages (on PASCAL Main Unit): ....... 38 7.2.4. Printer status messages (on printer): ..................... 39 7.2.5. PC status messages (from USB Adapter): ............. 40

7.3. Frequently asked questions .............................. 41 7.4. Tips and Tricks ................................................ 43

7.4.1. Optimizing patient cooperation ............................... 43 7.4.2. Working with SENSORCAP protective tip covers ...... 43 7.4.3. Working with SensorTips ........................................ 43 7.4.4. Working with the wireless printer ......................... 43

8. APPENDIX ........................................................... 44 8.1. Dynamic Contour Tonometry ............................ 44

8.1.1. Functioning principle of Contour Tonometry .......... 44 8.1.2. Comparing with applanation tonometry data .......... 44 8.1.3. "Unexpectedly different" results .............................. 45 8.1.4. Dealing with lacrimation .......................................... 46 8.1.5. Dynamic Tonometry vs. Static Tonometry ............. 47

8.2. How does PASCAL compute IOP and OPA? .... 48 8.2.1. The Q score ............................................................ 49

8.3. PASCAL Firmware Structure ............................. 50 8.4. Technical Specifications .................................... 51

8.4.1. Tonometer System ................................................. 51 8.4.2. Printer Accessory ................................................... 51 8.4.3. Rechargeable Battery Kit ........................................ 52 8.4.4. System Components .............................................. 53 8.4.5. Manufacturer’s EMC Declaration............................ 54

8.5. Accessories and Consumables ......................... 60 8.6. Warranty Information ......................................... 60 8.7. Service and Support Information ....................... 61

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

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


2. The PASCAL® WIRELESS System; enabled for wireless communication with printers and computers



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.

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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.

Note: Pressure curve as illustrated here cannot be observed with the basic PASCAL device. Only the numerical result is presented to user. Curve may be viewed as an output of the optional Printer accessory.

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 (page 7)

System Components provides an overview of the major components of the PASCAL Tonometer System, with illustrations showing all system components.

Section 3 (page 10)

Safety Instructions specifies the intended use of the PASCAL Tonometer and provides important guidelines for patient safety and operational safety. Please study this section carefully.

Section 4 (page 12)

Procedures provides step-by-step instructions on setting up and using the PASCAL device.

Section 5 (page 20)

PASCAL Operating Instructions contains systematic reference information on all procedures (IOP measurement, instrument settings, etc…).

Section 6 (page 29)

Care and Maintenance contains information on how to perform system checks and calibrations, on cleaning the device, and on maintenance and repairs.

Section 7 (page 35)

Troubleshooting contains a troubleshooting guide, a complete listing of error messages and status messages, and a “Frequently asked Questions” section.

Section 8 (page 44)

The Appendix contains background information on Dynamic Contour Tonometry, on system software, and on technical specifications.

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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 (as seen by patient)

Back side (as seen by user)

SENSORTIP™ (removable)

TIP CARRIER

CANTILEVER

MOUNTING BRACKET

Main Unit Housing

Battery Pack

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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.



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.



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.

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.

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 MAN

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USER MAN

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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 MAN

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USER MAN

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USER MAN

- 18

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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.

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.



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.



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



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.



Fig. 16: FW 4.01 Menu structure



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.



"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.



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 (sufficient to activate processor)

single beep PASCAL starts up, performs internal function test, then (after approx. 3 seconds) switches on LCD backlight and starts receiving data. If no signal above threshold is detected, shut-down after 60 seconds.

PASCAL is activated to take measurement

short click single beep start new measurement.

PASCAL is activated to take measurement

long click none measurement stopped. User Settings Menu is displayed, beginning with Prior Results list. If an IOP was already detected in current measurement, its result will appear in list.

measurement completed (Adequate Interrupt Maneuver)

None double beep; or two double beeps if Q>3

Result is displayed for 20s with backlight illumination, plus 40s without illumination.

within 60 seconds after measurement is terminated

short click none start new measurement.

within 60 seconds after measurement is terminated

long click none User Settings Menu is displayed, beginning with Prior Results list.

User Settings Menu short click single beep (double for “Volume”)

selected value is incremented.

User Settings Menu long click single beep scrolls to next menu item.

User Settings Menu (History and System info)

no click within 10s none Internal memory is checked, LCD goes off andPASCAL shuts down.

User Settings Menu (other items)

no click within 5s none Internal memory is checked, LCD goes off and PASCAL shuts down.



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)



– 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.

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.



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:

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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.



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" 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.

Fig. 18 Performance Test Kit



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.



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 Troubleshooting


Observed behavior Possible cause Action to take

Result shows Q score of 4 or 5.

Poor quality data (improper eye contact, excessive eye movement, electronic interference)

Discard measurement and repeat.

LCD Display is blinking and two double beep were heard after the interrupt manoeuvre instead of one



Result shows a number for IOP but “OPA = n/a” even though you can hear the 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 IOP but “OPA = n/a”, and the sound heard during measurement does not seem to oscillate in pitch.

Patient has a very low OPA (OPA < 0.5 mmHg.)

Device unable to detect such a small OPA. Note OPA as “not detectable”.

Error Message: “Check Tip!, no Tip.”

No SENSORTIP in Tip Carrier Insert a SENSORTIP

Bad contact; SENSORTIP not fully inserted into Tip Carrier

Push SENSORTIP fully into Tip Carrier; wipe contacts clean on Tip and in Tip Carrier.

Calibration value out of range or not available

Send tip to Service Center for recalibration or repair.

Error Message “Check Tip!, OTF Error.”

check of the overall pressure transfer function failed

Send tip to Service Center for recalibration or repair.

Error Message “Check Tip!, CRC Error.”

redundancy check failed Send tip to Service Center for recalibration or repair.

Black square blinking on LCD (rightmost position)

Battery almost empty Replace Battery Pack.

Warning message: “battery low, replace soon”

Battery almost empty Replace Battery Pack.

Two black squares blinking Battery empty. No further measurements possible.

Replace Battery Pack immediately.

Warning message: “battery empty!, replace”

Battery empty. No further measurements possible.

Replace Battery Pack immediately.

Test printout was printed on the wrong printer

While searching for available printers, another printer was found before the wanted one.

1) Do not acknowledge the message “print correct, confirm=click” 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 does not match with the one on the PC screen

While searching for available computer, another PC was found before the desired one.

1) Do not acknowledge the message “ID …, confirm=click” 2) Let PASCAL find another PC 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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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 is currently not available.

1) Ensure PASCAL is switched on.

2) Retry to reopen the COM port.

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



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.



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.



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.



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.

P

d

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RC Radius of Cornea RT Curvature Radius of Tonometer Tip F appositional force FP internal force generated by IOP d diameter of contact area AC P intra-ocular pressure (IOP)

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

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.



Therefore, if someone finds, for example, 15 mmHg with Goldmann and the same result with an air tonometer, but, say, 19 mmHg with the PASCAL, such a result is not at all "impossible" or "incredible" or "false". It may be hard to believe against a background of decades of experience with what is still referred to as a "Gold Standard". However, people should be reminded that it is a proven fact that applanation delivers false results in certain circumstances. What is less well known is just how large the error can often be.

Of course, any instrument may furnish faulty results under certain conditions. This can certainly also happen, and has been seen, with the PASCAL tonometer. Possible reasons may be:

PASCAL tip not correctly centered on the eye.

Extremely flat corneas which adhere to the entire tip surface.

SensorCap not properly mounted -- air bubbles or wrinkles in the membrane.

Physically damaged SENSORTIP, with an uneven surface (e.g. caused by partial delamination of the coating of the contact surface, or mechanical damage caused by attempted vigorous cleaning).

Poor data quality (with a Q > 3), due to poor patient cooperation, or too short measurement time, or low OPA (<1 mmHg).

Poor lacrimation of patient’s cornea; or excessive lacrimation. These two conditions can have a major effect on the quality of the data generated, and need to be managed carefully. This topic will be discussed in detail further below (see section 8.1.4).

It is therefore always a good practice to check your result (including the Q value shown on the LCD) and your instrument (whether it looks initially "believable" or not) and, when in doubt, to perform a second measurement. Most of the conditions which may give rise to errors can be seen and corrected when carefully observing the cornea – tip interface.

Only a minority of the potential causes for measurement errors listed above are patient-related. These deserve special discussion as they can be managed if their consequences are properly understood.

8.1.4. Dealing with lacrimation

Excessive lacrimation: If there is too much liquid on the cornea, the SENSORTIP may actually not touch the eye. It will "float" on the excessive liquid (this may happen more frequently with flat corneas than with steep corneas; Fig. 20). In this case you are likely to get very low IOP values and no real oscillation (irregular curve, irregular sound with no clear oscillation pattern; often poor Q value). Removing the excess liquid from the eye and from the SENSORTIP will help to get a correct measurement.

Poor lacrimation / dry eye: For PASCAL measurements it is important to have a complete tear film between cornea and SENSORTIP surface. If part of the interface is completely dry, this may cause the cornea to stick to the SENSORTIP. If that happens, you will notice that when moving the slit lamp, the contact area will not move freely, but the eye is pulled along with the SENSORTIP. It is easily seen that this will cause extreme distortion forces to occur in the cornea, leading to readings which may be up to 2x IOP. Another situation that may occur with poorly wetted corneas is that you do not see a complete circular contact area, but a contact area with irregular borders (this is most frequently seen on the top part which tends to run dry first due to gravity; Fig. 22). In this situation it may help to add some liquid (artificial tears, preferably a low viscosity variety; or more anesthetic drops). Incidentally, this situation may also occur in applanation tonometry. But if there is insufficient liquid, there will be insufficient Fluorescein and therefore no fluorescent ring, prompting the observer to almost automatically instill some more drops. Insufficient lacrimation also creates a risk of epithelial erosion from moving around with the tip (Goldmann or PASCAL) on the cornea.

Hence two important rules:

Excessive lacrimation: low PASCAL readings. Remove excess liquid.

Poor lacrimation: high PASCAL readings. Add drops.



Fig. 20: excessive lacrimation: entire

lens filled with tear fluid. Fig. 21 regular pattern: contact area is

circular and smaller than total lens diameter.

Fig. 22 poor lacrimation; tear-film breaks up from top.

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.



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.



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).



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

(Wireless enabled systems only)

NO YES

NO

NO

Shut Off

Long Click

Recording Mode

Stop recording

Long Click

Short Click

SENSORCAP Reminder

Recording Message

beep

Stop & restart

Settings Mode

Compute

Interrupt?

Display Result

History List

Settings*) 2xbeep

YES

NO

YES

YES

NO

initialize

Printer on YES

Print Report

*) for details on Settings Mode see



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 System:

311.011.001 or 311.011.002

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 WIRELESS systems only):

PASCAL®

Model No. 311.011.001 / 002

Contains FCC ID: POOWML-C10XX

IC labeling (Canada) (PASCAL WIRELESS systems only):

IC: 5508A-PASCAL

(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 (PASCAL WIRELESS systems only):

Up to 10 meters (30 feet) inside same room

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: [email protected] 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



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: secondary voltage:

100 – 240 V AC ± 10% 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



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 S1 / S2

Complete System, standard version, based on S1 or S2 Main Unit

311.101.001 / 002 Main Unit S1 / S2 Main Unit (standard version) with S1 / S2-type mounting bracket

311.011.001 / 002 PASCAL WIRELESS System S1 / S2

Complete System, wireless-enabled version, based on S1 or S2 Main Unit

311.111.001 / 002 Main Unit, WIRELESS

Main Unit (wireless-enabled version), with S1 / S2-type mounting bracket

311.640.001 / 002 Attachment Kit S1 / S2

Attachment screws and Torx wrench for S1/S2-type Main Units (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 Downloader

(System comes with this small utility program and its corresponding user manual)

311.951.001 User Manual (System comes with a User Manual in English; supplied on CDROM)

311.951.101 Quick Reference Sheet

(System comes with a laminated Quick Reference Sheet in English Language).



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 (to be used in lieu of disposable batteries included with System).

n/a

WARNING

The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the equipment or system.



Table 201:

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

CISPR 11

Group 1 The EQUIPMENT uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

CISPR 11

Class B The EQUIPMENT is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Not applicable

Voltage fluctuations/flicker emissions

IEC 61000-3-3

Not applicable



Table 202:

Guidance and manufacturer’s declaration – electromagnetic immunityThe 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

Test level

Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

± 6 kV Contact discharge

± 8 kV Air discharge

± 6 kV Contact discharge

± 8 kV Air discharge

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst

IEC 61000-4-4

Not applicable

Not applicable

Surge

IEC 61000-4-5

Not applicable

Not applicable

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

Not applicable

Not applicable

Power frequency (50/60Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.



Table 204:

Guidance and manufacturer’s declaration – electromagnetic immunity The EQUIPMENT is intended for use in the electromagnetic environment specified below. The customer or the user of the EQUIPMENT should assure that it is used in such an environment.

Immunity tests IEC 60601

Test level

Compliance level Electromagnetic environment - guidance

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

IEC 61000-4-6

Not applicable Not applicable Pd 2.1

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m Pd 2.1 80 MHz to 800 MHz

Pd 3.2 800 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 determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b

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.



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.

Rated maximum output power of transmitter (P)

W

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz

Pd 2.1

80 MHz to 800 MHz

Pd 2.1

800 MHz to 2.5 GHz

Pd 3.2

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.



Disposal of Equipment

The electronic components of the PASCAL® Dynamic Contour Tonometer are subject to the European Union Directive 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 [email protected]



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 Kit

Battery Charger Kit (110/220V), with two rechargeable batteries (to be used in lieu of disposable batteries included with System).

311.620.001 Test Kit for performing pressure sensor calibration checks.

311.951.002 Other Language User Manuals

PASCAL® User Manual in foreign language versions; electronic version, PDF Format, on CDROM.

Consumables:

311.751.002 Replacement Batteries, disposable

5 disposable batteries, as replacement for the 2 batteries included with system. NOT RECHARGEABLE.

311.761.105 Replacement Batteries, rechargeable

2 rechargeable batteries (Battery Charger p/n 311.761.001 is required).

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.



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: [email protected]

website: www.ziemer-ophthalmics.com

Phone: +41 32 332 7050

Mail Address: Ziemer Ophthalmic Systems Group AG Allmendstrasse 11 CH-2562 Port (Switzerland)

6100-50-0005-04 pascal user manual en

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