Ocular Response Analyzer Sw Ver 2.0 Users Guide Rev C

©2009 Reichert, Inc. Reichert and Ocular Response Analyzer are registered trademarks of Reichert, Inc. The information contained in this document was accurate at time of publication. Specifications subject to change without notice. Reichert, Inc. reserves the right to make changes in the product described in this manual without notice and without incorporating those changes in any products already sold. Federal law restricts this device to sale by or on the order of a physician. ISO 9001 Certified – Reichert products are designed and manufactured under quality processes meeting ISO 9001 requirements. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, recording, or otherwise, without the prior written permission of Reichert, Inc.



13880-101 Rev. C

Table of Contents

Preliminary Information

Table of Contents Warnings and Cautions

Getting Started

3 4

Introduction Unpacking and Preparing for Use Features and Connections Setup and Installation

5 6 7 8

Instrument / Software Use

Software Overview Demonstrating the Air Puff Taking Patient Measurements Viewing Patient Measurement Data Printing Measurement Data Export Function

10 14 15 20 26 27

Measurement Signal Information

Analyzing Measurement Signals

29

Care and Troubleshooting

Cleaning and Maintenance Troubleshooting

30 31

Important Information

Specifications Classifications and Compliance Guidance Tables Symbol Information Reichert Warranty

32 33 34 38 39

Contact Us

Reichert, Inc Contact Information

Back Cover

13880-101 Rev. C



Warnings and Cautions

WARNING: AN INSTRUCTION THAT DRAWS ATTENTION TO RISK OF INJURY OR DEATH. CAUTION: AN INSTRUCTION THAT DRAWS ATTENTION TO THE RISK OF DAMAGE TO THE PRODUCT. WARNING: USE OF THE OCULAR RESPONSE ANALYZER IS CONTRAINDICATED IN INSTANCES OF: - ULCERATED CORNEAS - FOLLOWING KERATOPLASTY - FOLLOWING PENETRATING TRAUMA WARNING: THE OCULAR RESPONSE ANALYZER SHOULD BE USED IN STRICT ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN THIS USER’S GUIDE. THE SAFETY OF THE OPERATOR AND THE PERFORMANCE OF THE INSTRUMENT CANNOT BE GUARANTEED IF USED IN A MANNER NOT SPECIFIED BY REICHERT, INC. WARNING: IN ORDER TO ENSURE THAT CORRECT OPERATION OF THE INSTRUMENT IS MAINTAINED, AND TO GUARANTEE THE SAFETY AND RELIABILITY OF THE INSTRUMENT, ANY REPAIR OR SERVICE MUST BE PERFORMED BY REICHERT, INC. OR AN AUTHORIZED SERVICE AGENT OF REICHERT, INC. WARNING: THE INSTRUMENT MUST BE PLUGGED INTO AN OUTLET WITH AN EARTH GROUND. DO NOT REMOVE OR DEFEAT THE EARTH GROUND CONNECTION ON THE OCULAR RESPONSE ANALYZER POWER INPUT CONNECTOR OR THE UNIT’S POWER CORD OR DAMAGE TO THE OCULAR RESPONSE ANALYZER AND/OR INJURY TO THE OPERATOR OR PATIENT MAY OCCUR. WARNING: THE AREA SURROUNDING THE OCULAR RESPONSE ANALYZER NOSEPIECE MAY CREATE A “PINCH HAZARD”. DO NOT PLACE FINGERS INTO THE OPENING SURROUNDING THE NOSEPIECE. WARNING: THE USE OF ACCESSORIES OR CABLES OTHER THAN THOSE SPECIFIED, WITH THE EXCEPTION OF THOSE SOLD BY THE MANUFACTURER AS REPLACEMENT PARTS FOR INTERNAL COMPONENTS, MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE EQUIPMENT OR SYSTEM. WARNING: THE EQUIPMENT OR SYSTEM SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT AND THAT IF ADJACENT OR STACKED USE IS NECESSARY, THE EQUIPMENT OR SYSTEM SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN WHICH IT WILL BE USED. CAUTION: THE INTERNAL CIRCUITRY OF THE INSTRUMENT CONTAINS ELECTROSTATIC DISCHARGE SENSITIVE DEVICES (ESDS) THAT MAY BE SENSITIVE TO STATIC CHARGES PRODUCED BY THE HUMAN BODY. DO NOT REMOVE THE COVER OF THE OCULAR RESPONSE ANALYZER WITHOUT TAKING PROPER PRECAUTIONS OR DAMAGE TO THE INSTRUMENT MAY OCCUR. CAUTION: DO NOT USE SOLVENTS OR STRONG CLEANING SOLUTIONS ON ANY PART OF THE INSTRUMENT OR DAMAGE TO THE UNIT MAY OCCUR. SEE THE MAINTENANCE SECTION FOR DETAILED CLEANING INSTRUCTIONS. CAUTION: this instrument is not suitable for use in the presence of flammable anesthetic mixtures such as oxygen or nitrous oxide. CAUTION: mEDICAL ELECTRONIc EQUIPMENT NEEDS SPECIAL PRECAUTIONS REGARDING EMC AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC INFORMATION PROVIDED IN THE ACCOMPANYING DOCUMENTS. CAUTION: PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT. CAUTION: This instrument is not to be used NEAR high-frequency EMITTING surgical equipment.



13880-101 Rev. C

Introduction

Congratulations on your purchase of the Ocular Response Analyzer. The Ocular Response Analyzer is a revolutionary instrument designed to measure the intraocular pressure of the eye and biomechanical properties of the cornea in one simple, fast measurement. The instrument has an innovative automatic alignment system that eliminates operator subjectivity and provides precise, repeatable measurements. This User’s Guide is designed as a training and reference manual for operation, maintenance, and troubleshooting. We recommend that you read it carefully prior to use and follow the instructions in the guide to ensure optimum performance of your new instrument. If used properly, the Ocular Response Analyzer will provide you with fast, accurate and reliable measurements for many years. Please retain this manual for future reference and to share with other users. Additional copies can be obtained from the Reichert Customer Service Department. Contact information is provided at the end of this guide.

13880-101 Rev. C



Unpacking, Preparing for Use, and Packing

Unpacking and Contents Great care has been taken to deliver your instrument to you. The packaging was specially designed to transport this device. Please retain the packaging for future use in case transportation is required. To remove the components: 1. 2. 3. 4. 5.

Remove the top foam piece from the shipping container. Remove the accessories. Remove the upper foam piece from the Ocular Response Analyzer measurement head. Lift the unit out of the box using the handle-slots in the cardboard cradle. Unfold the cradle, remove the plastic bag from the instrument, and set the unit in a safe location.

The items listed below should be included in the package. If any of these items are missing, please contact the Reichert Customer Service Department. Contact information can be found on the back page. • • • • •

Ocular Response Analyzer measurement head Dust cover Phillips screw driver Power cord User’s guide NOTE: All parts of this system are suitable for use in the patient environment.

Place the unit on an adjustable height instrument stand in a clean, dry, temperature controlled environment (50 - 110° F / 10 - 43° C). Keep away from direct sunlight, bright lights, and Infrared (IR) light-generating devices. Disengage Travel-Lock NOTE: It is very important to disengage the travel-lock before applying power to the Measurement Head. The Ocular Response Analyzer’s automatic alignment system utilizes sophisticated electronic motors. To ensure that the motors are not damaged during shipment, the instrument features a travel-lock to hold the components securely in place. 1. 2. 3.

Locate the travel-lock-screw access hole in the back cover of the instrument (see page 7). Insert the Phillips screwdriver into the travel-lock hole and feel for engagement with the screw. Turn the screw counterclockwise at least six full turns (the screw remains inside the travel lock hole).

Application of Input Power 1. Insert the female end of the power cord into the power input receptacle located on the side of the instrument near the bottom (see page 7). 2. Plug the male end of the power cord into a wall outlet of the appropriate voltage. Input voltage must not exceed the range specified on the instrument data plate. An appropriate wall socket adapter may be required depending on your wall-outlet style.

Engaging the Travel-Lock (to be performed only when shipment of the instrument is required) Before shipping the unit for any reason, the instrument must be parked and the travel-lock must be engaged. 1. Click the Park Button found on the System Setup Tab of the Tools/Options Menu (see page 12). The software will display a message when the head is “parked.” 2. Locate the travel-lock-screw access hole in the back cover of the instrument (see page 7). 3. Insert the Phillips screwdriver into the travel-lock hole until contact with the screw is made (see page 7). 4. Push the screw inward, compressing the retainer spring, and turn the screw clockwise until tight. Failure to engage the travel-lock prior to shipment may result in damage to the unit and may void the warranty. 

13880-101 Rev. C

Features and Connections

System Part Identification 1. Forehead Rest: Comfortable left/right sliding headrest used for patient positioning and stabilization. 2. Nosepiece: Air tube where “air puff” originates. Green LED patient fixation target is visible inside this tube. 3. Canthus Marks: Alignment marks for proper positioning of instrument-to-patient-eye height. 4. Travel Lock: Locking mechanism that protects internal components during shipment. 5. Power Indicator: Blue LED indicates measurement head is turned ON. 6. Communication Port: RS-232C port for connection to system PC. 7. On / Off Switch: Rocker-switch used to turn the instrument on and off. The “up” position (_) is on. 8. Power Input Receptacle and Fuse Holder: Input for AC power cord and location of fuses. 9. Computer Connection: RS232 serial cable connection on PC.

1 2

3

4 5

Travel-lock & Power Light

Patient Interface

6

7

8

9

Connections & Power

PC connection A typical PC is shown here. Not all PC’s will be the same. USB or PCMCIA adapters can be used on computers that do not have a serial port.

13880-101 Rev. C



Setup and Installation

Setup and PC connection The Ocular Response Analyzer must be set on an adjustable height instrument stand and connected to a PC. The system is sold in various configurations, so these items may need to be obtained independently if they were not provided with the instrument. NOTE: It is essential to disengage the travel lock before turning the instrument on. See page 6 for instructions. System Configuration The installation shown on the left shows the patient side of the instrument facing the same direction as the operator interface. This enables the system to be positioned close to a wall, conserving space. It also allows operators to directly observe instrument / patient alignment. Alternate configurations are possible, depending on the needs of the operator. Connect the RS232 cable from the COM port on the instrument to the serial input on the computer. USB-serial or PCMCIA adapters may be used for computers that do not have a serial port. Use the Windows control panel to identify the COM port that a serial adapter is installed on, then set the ORA software to the same COM port using the Tool/Options/system setup settings. Software Installation Turn on the computer and insert the provided Ocular Response Analyzer software CD. The software will automatically run and guide the operator through the installation process. Installation Wizard Once the software installation process has begun, a dialogue box will appear asking if your Ocular Response Analyzer features a built-in ultrasound pachymeter. Click YES if your instrument features a builtin, contact, 20 MHz ultrasound pachymeter. Click NO if your unit does not have a pachymeter. NOTE: For Pachymeter operating instructions please see the 13880-101 Rev B user manual



13880-101 Rev. C

Setup and Installation

Installation Folder: The software will be installed on the computer in the following location unless otherwise specified by the operator: C:Program FilesReichertORA

User Information: A User Name and Company Name must be entered. For Example: User Name: Dr. William Jones Company Name: Better Vision Center This information will be archived along with patient measurement data and will appear on the measurement result print out.

Once the software is installed, an icon like the one shown on the left will appear on the PC desktop. Double click the icon to begin using the software.

13880-101 Rev. C



Getting Started / Software Overview

Using the Software The Ocular Response Analyzer PC software package controls the functions of the measurement head and allows for archiving of measurement data. There are text menus and icon-based buttons, many of which perform the same tasks, to suit different user preferences. Initial Screen Control Menus Control Icons

Workspace

Status Display Control Icons (buttons) and File Menu functions

File Menu - Click the File Menu items or Control Icons to access the following modes or functions: Measure (Quick or Normal) Quick mode can be accessed by clicking the small arrow immediately to the right of the Measure Icon. This mode enables operators to proceed immediately to the measure screen without entering patient information into the database. Results can be archived after measurements are obtained. Normal mode requires operators to enter patient information before proceeding to the measure screen. All measurement data taken in Normal mode will be archived into the database. Review - Enter this mode to examine existing patient data for on-screen review or printing. Print - Enables printing of patient data on optional color printer. Exit - Click to close the software. View Menu - Click the View Menu to access the following functions: Tables - Enables operators to edit database groups and races. Statistics - Click to view population data by group, race, and sex for all patients in an existing database. Tools Menu - Click the Tools Menu to access the following function: Demo Puff - Enables operators to demonstrate the air-puff to patients before beginning an exam. Export - Enables export of patient data for use in other applications such as spreadsheets or databases. Options - Enables operators to modify various system settings. Window Menu - Click to bring a selected window to the forefront from a list of currently open screens. Help Menu - Contains information about the Ocular Response Analyzer software package.

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System Options

System Options To modify system settings, click on the Tools Menu and select Options. There are four tabs containing various system setting options. General Tab The General Tab on the Options Window enables users to customize a number of software features: The maximum number of measurements per eye can be set (maximum of four). The default plot setting for the View Measurement(s) Screen can be selected. The filtered signal curve can be turned on or off. The Ocular Response Analyzer uses a mathematical signal filter to calculate final values from the raw measurement signal. If desired, the operator can view the filtered signal by enabling this check box. To prevent accidentally closing the software, users can enable the Confirm on Exit check box at the bottom of the General Tab.

General Tab - Database Location and Database Backup

The default database filename is ora.mdb. The default location of the database is: Windows XP: C:Documents and SettingsAll UsersApplication DataReichertORA Windows Vista: C:UsersPublicDocuments ReichertORA Users can rename the database, create multiple databases, or change the location of databases if desired. Click the button to the right of the database path to select the desired database. Databases can be stored on a shared network drive and accessed from any PC with the ORA software installed. A Backup Location for databases can be specified and the desired backup frequency can be set.

13880-101 Rev. C

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System Options

System Setup Tab The System Setup Tab on the Options Window enables users to modify the following options: Communications Port This setting controls which COM port the software will use to receive data from the measurement head. RS232 serial ports are typically COM 1 or COM 2. USB to Serial adapters or PCMCIA to serial adapters will assign a COM number that is not currently in use on the PC. Use the Windows Control Panel to identify the COM port of a serial adapter device. Park Park the instrument before locking in preparation for transport. See page 6 for details on parking and locking. Information Tab The Information Tab enables users to modify the User name and Company name. This information is stored in the database and appears on the printout.

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13880-101 Rev. C

System Options

Views Layout Tab The Views Layout tab enables users to configure the headers that will be visible in the patient data window. Users should check the options that they wish to see when they are viewing, sorting, or searching the patient database. See page 15 for further information on patient information viewing and sorting.

View Tables Options Click the View Menu and select Tables to add, edit, delete, or reassign the group names, race categories, and plot options utilized throughout the Ocular Response Analyzer software. View Tables Window To edit Groups, Races, and Plots settings, select Tables from the View Menu. The View Tables Window contains three Tabs: Groups, Races, and Plot. Operators may use the Add Button to create additional Groups or Races. Existing Groups and Races can be edited or deleted using the respective buttons. When a group or race is deleted, the operator will be given the option to delete the category only, or the category and the contents. Deleting the category only enables the operator to reassign the patient data to a different category, rather than deleting the data. Operators can also use the Reassign button to reassign data from one group or race category to another. Click the Close Button when finished.

13880-101 Rev. C

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Demonstrating the Air Puff

Demo Puff Before measuring a patient it may be helpful for operators to demonstrate the air puff so that the patient will know what to expect. With the patient seated comfortably in front of the instrument the operator should instruct the patient to hold a hand a few inches in front of the air tube, where the red fixation lights are visible. Initiating the Demo Puff Select Demo Puff from the Tools Menu to bring up the Demo Puff Dialog Window. Click the Demo Puff Button to initiate the air puff. The button can be pressed as many times as desired. Click the Close Button when finished.

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13880-101 Rev. C

Taking Patient Measurements

Initiating a Measurement There are two measurement modes: Quick and Normal. Quick Mode is accessed by clicking the Arrow next to the Measure Icon. This immediately brings up the Measurement Window, bypassing the entry of patient information. Measurements made in Quick Mode cannot be printed. However, patient information and results can be saved afterwards, allowing the device to be used as a screening instrument, but providing the flexibility to save the patient data if remarkable results are discovered. Normal Mode requires entry of patient information such as Name, Birth Date, etc. Results are archived when using Normal Mode. Click the Measure Icon to use the Normal Mode. Normal Measurement Mode: Patient Selection Window The Patient Selection Window displays the list of existing patients. Operators can sort the patient list in ascending or descending order by clicking on the headers. Visible headers can be modified in the Views Layout Tab (see page 13), Operators can also search by patient name, edit existing patient data, or merge existing patient records using the respective buttons. All patient names can be displayed at once, or a specific Group can be viewed. The Group Function is used to create separate patient data archives. New Group names can be added by clicking Add New from the Selected Group list. Click the New Patient Button to enter a new patient into the database. To measure an existing patient, double click the name of the patient from the Existing Patient List. New Patient Data Entry Window After clicking the New Patient Button, the New Patient window will appear. All fields indicated by an asterisk (*) are required. The software will not allow a patient birth date of the current date to be entered. The ID field automatically generates a sequential patient ID number. Patient Data Field 1 and Patient Data Field 2 are open text fields for additional identification information. Operators may press the New Patient Button again to continue entering new patients into the database or highlight one of the names on the list and click Next, or double-click the name, to advance to the Notes Window.

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Taking Patient Measurements

Patient Measurement Notes After choosing a patient from the Patient Selection Window, operators can enter notes into the following optional fields: Medications, Conditions, Exam Notes #1, and Exam Notes #2.

There are separate Notes Fields for each eye. The Medications, Conditions, Exam Notes #1, and Exam Notes #2 fields are associated only with the measurements made during a particular measurement session. These notes can be updated at the time of each exam and the history will remain intact. This is helpful for tracking medication changes, condition changes, etc. Clicking the check boxes between the fields automatically transposes text from one eye to the other to save keystrokes. When making a new measurement on an existing patient the notes from the last session will appear. These can be left as is, or modified to reflect any changes. Click the Measure Button when finished. Measurement Window The Measurement Window enables operators to initiate a measurement and to see the resultant numerical data. The Measure Response Button initiates automated alignment and measurement. NOTE: For Pachymeter operating instructions please see the 13880-101 Rev B user manual.

Right Eye Data Window Right Eye Delete Data Button Left Eye Data Window Left Eye Delete Data Button Measure Response Button Measure Eye Indicator

Done Button Cancel Button

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13880-101 Rev. C

Taking Patient Measurements

Patient Positioning Proper patient positioning promotes fast and accurate measurements. Patients should remove contact lenses, loosen tight collars and ties, and be relaxed. Operators should inform patients that nothing will touch their eye and that they will only feel a very gentle puff of air. It may be helpful to demonstrate the air puff to patients before the exam. See page 14 for details. The Ocular Response Analyzer features a left / right sliding forehead rest that enables the software to automatically determine which eye is being measured. It must be positioned completely to one side or to the other in order to take a measurement. A properly-positioned patient will easily see the fixation cues. The fixation target is a green light, located inside the air tube, surrounded by a ring of red lights. In order to take a measurement, patients must be fixating on the green light. If a patient is unable to see the green light, the operator should verify that the patient can see any of the red lights. If any red lights can be seen, the automatic alignment system will bring the green fixation target into view. Set the height of the table so the canthus marks on the sides of the instrument are level with the patient’s eyes. Patients should lean forward slightly so that the center of their forehead rests in the middle of the rubber forehead pad. The patient’s head should contact the headrest straight-on; perpendicular to the front of the instrument (not turned to the side). In addition, the patient’s nose and chin should be inward, towards the front surface of the unit.

Correct Patient Positioning

To ensure fast and accurate results operators should instruct the patient to blink a few times and hold both eyes open immediately before clicking the Measure Response Button. Remind the patient to look directly at the green light and hold steady. Observe the photo on the left. Notice the distance between the patient’s chin and the front of the instrument. The instrument is too low, causing the patient to rest her head in a downward-facing manner. In this instance, the patient may not be able to see the fixation target, and the alignment system may not be able to find the patient’s eye.

Incorrect Patient Positioning 13880-101 Rev. C

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Taking Patient Measurements

Making Measurements The position of the sliding forehead rest controls which eye will be measured. Slide the forehead fully to the left or right and position the patient properly (see the Patient Positioning section) to take a measurement. The First Measurement To take a measurement, simply click the Measure Response Button. The system will automatically align to the apex of the cornea and the instrument will take a measurement. The signal will be displayed and the measurement results will appear in the right or left eye data window, depending on which eye was measured. Up to four measurements can be taken per eye. To ensure the reliability of the measurement data, operators should look at the Waveform Score (WS) on the lower right of the signal window. The waveform score is presented on a scale of zero (0) to ten (10). The higher the number, the more reliable the measurement data will be. Unreliable signals can be deleted by highlighting the desired measurement values and then clicking the delete button (x). Taking Multiple Measurements on the Same Eye It is recommended that operators take multiple measurements on each eye so that the signals can be evaluated for consistency to ensure accurate results. A maximum of four signals and measurement result lines can be displayed at once. When multiple measurements are taken, the signal with the highest waveform score will automatically be selected as the Best Signal Value (BSV). This is the signal that the final results will be based on. This measurement will be identified as such when viewing the patient data in the View Measurements window described later in this guide. Operators may need to take additional measurements, deleting unacceptable signals, until acceptable results are obtained. Eyes with irregular corneas or pathology may make obtaining a reliable signal more difficult. Some eyes may never produce “normal” signals. 18

13880-101 Rev. C

Taking Patient Measurements

Measuring the Second Eye After completing the number of desired measurements on the first eye, operators should slide the headrest fully to the other side and reposition the patient for measurements on the second eye. Second Eye, First Measurement Once the patient is repositioned, simply click the Measure Response Button again. When the first measurement for the second eye is taken, the measurement signal will appear on the screen. Operators can click on the left or right eye data windows to switch back and forth between the signals from either eye. When the desired number of measurements has been obtained for both eyes, the operator must click the Done Button to proceed to the View Measurement Window.

Done Button

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Viewing Patient Measurement Data

View Measurements Window The View Measurement Window displays patient measurement results graphically on a plot. This window automatically appears after taking patient measurements and clicking the Done Button. Operators can also access this mode by clicking the Review Icon or selecting Review from the File Menu (CTRL + R) and then choosing the patient to be reviewed. Printing Results Measurement data can also be printed using the Print button, accessible from this screen. See the Printing Patient Data section of this guide for details.

1. References and signal pop-up 2. Measurement History 3. Data Plot Area 4. Eye Selection 5. Measurement Display Mode 6. Notes Tab / Options Tabs 7. Patient Notes window

8. New Measure Button 9. Close Button 10. Drawing Properties Button 11. Rescale Button

Features and Functions of the View Measurements Window This screen is a powerful patient data analysis tool that displays patient data in a number of formats. Detailed descriptions of the features, functions, and buttons are provided below: 1. References and signal pop up- Displays measurement data corresponding to a specific measurement.

Operators can hover the mouse pointer over any data point in the Data Plot Area to view the numerical data from that measurement. In addition, a small “thumbnail image” of the measurement signal will pop up below the numerical data along with the corresponding Waveform Score (WS). As an alternative to hovering over data points with the mouse pointer, operators can click on any checked line in the measurement history list to view the references for that measurement. The References window can be hidden if desired by clicking on the arrow to the right of the word ‘References’.

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