® ADVANCED User’s Guide
009 Reichert, Inc. Reichert is a registered trademark 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.
Table Of Contents Warnings & Cautions ............................................................................................................................................................................. 4 Symbols................................................................................................................................................................................................... 6 Explanation of Symbols ......................................................................
Warnings & Cautions Reichert, Inc. (Reichert) is not responsible for the safety and reliability of this instrument when: • Assembly, disassembly, repair, or modification is made by unauthorized dealers or persons • Instrument is not used in accordance with this User’s Guide WARNING: AN INSTRUCTION THAT DRAWS ATTENTION TO RISK OF INJURY OR DEATH. WARNING: United States Federal law and European regulations require that this device be purchased only by a physician or a person acting on behalf of a physician.
performed. The American Institute of Ultrasound in Medicine (AIUM) has a publication “Medical Ultrasound Safety” (1994) which has more information on this topic. CAUTION: This device has not been tested in conjunction with HF surgical (e.g. electrocautery) equipment and should not be used with such equipment. CAUTION: When removing the protective cap from the transducer be careful not to pull too hard.
Symbols Explanation of Symbols Type BF Patient-applied parts are insulated. Catalog Number SN Serial Number Attention, See Instructions for use Date of Manufacture Waste of Electrical and Electronic Equipment Conformity with mandatory European Safety requirements 6 16012-101 Rev.
Introduction Congratulations on your purchase of the IOPac Advanced pachymeter. This User’s Guide is designed as a training and reference manual. We recommend you carefully read and follow the steps in this guide to ensure optimum performance from your new instrument. Please retain this guide for future reference and to share with other users. Additional copies can be obtained from your authorized Reichert, Inc.
Introduction (Continued) User Interface The IOPac is a Palm Powered device. For documentation on the Palm interface, Graffiti text entry system and other general aspects of the Palm operating system please refer to the help file located on the Palm CD that is supplied with the IOPac. Data can be entered by either using the Graffiti interface or the internal keyboard. Tapping 123 located on the lower right corner on the IOPac screen activates the numeric keyboard.
IOPac Setup Great care has been taken to deliver your new IOPac Advanced pachymeter safely to you. The container and packaging was specially designed to transport this unit. Please retain this packaging for any future use if transportation is required. This IOPac Pachymeter is intended for measuring corneal thickness of the human eye using ultrasound technology. It features a 20 MHz probe capable of an accuracy of ±5 µ m. The measurement takes 1 – 2 seconds.
IOPac Setup (Continued) Parts Identification 5 3 1 4 6 2 Parts: 1. Charging Power Cord 2. USB Cord 3. Power Adapters 4. IOPac Advanced 5. Graffiti Labels 6. Ultrasound Probe 7. Stylus (attached to the Palm) 8. Manuals and Software Disks (not shown) 10 16012-101 Rev.
Instructions for Use Turning On and Off The power button is located on the front of the IOPac. Press it once to turn the instrument ON or OFF. The IOPac has an inactivity timer set to 3 minutes after which it will shut off. Data will NOT be lost if the unit shuts off automatically. Stylus Power Button When turning on the instrument for the first time the main screen will appear.
Instructions for Use (Continued) Start Measuring Central Corneal Thickness (CCT) Measurement Preparation of the Patient The patient should be in a seated position. It may be helpful to explain that they should relax and attempt not to blink as the probe is going to gently contact their eye. A drop of ocular anesthetic should be placed in the eye or eyes that are going to be measured. If the patient has dry eyes, a moisturizing drop may also be used.
Instructions for Use (Continued) Start Measuring Central Corneal Thickness (CCT) Measurement (Continued) Acquiring a Measurement Caution: Do Not use the ultrasound probe as a stylus. This will cause damage to the probe and void the IOPac warranty. The Measuring screen shows both the right (OD) and left (OS) eyes. The instrument will default to the right (OD) eye. You can switch the eye that you want to measure by tapping either the OD or OS box at the top of the screen. To start measuring, tap: Start.
Instructions for Use (Continued) Start Measuring Central Corneal Thickness (CCT) Measurement (Continued) Calculating a Corrected IOP (Intraocular Pressure) Tap IOP at the bottom of the Measuring screen. Select the Correction Method from the pull down menu by tapping Correction Method. You can select: 2-way Lookup Table, Reference Formulas 1 to 4, or Custom Formulas 1 to 3. Please see the IOP Formulas section of this manual for more detail.
Instructions for Use (Continued) Risk Estimate Calculating Glaucoma The Glaucoma Risk Calculator feature provides you with a measure of the percentage of risk that a patient might develop glaucoma within the next 5 years. The risk calculation algorithm is based on the methods proposed by Medeiros, et al. (*) using risk factors identified in the Ocular Hypertension Study (OHTS).
Instructions for Use (Continued) Risk Estimate (Continued) Risk Factors Age Patient's age in years, entered manually in all cases Avg. Baseline IOP Average Baseline Intraocular Pressure. This value must be entered manually in all cases. Units are mmHg. Avg. OS,OD CCT Average Right Eye/Left Eye Central Corneal Thickness. This value is entered automatically when using the current exam measurement or a patient file from the database.
Instructions for Use (Continued) View Database To view saved entries, tap View Database on the main startup screen. You can select an examination by highlighting the examination line and tapping View, or by double tapping the examination line. Examinations are sorted by examination date – starting from the most recent.
Instructions for Use (Continued) Using the Refractive Module The Refractive Module allows data from non-central areas of the cornea to be stored in an easy and intuitive way. This feature is particularly useful for refractive procedures such as Conductive Keratoplasty. Preparation of the patient Follow the same patient preparation used when taking a standard CCT measurement.
System Menu Screen The system menu screen is accessed by touching the “Reichert Pachymetry” menu at the top and left of the screen with the stylus. When the “Reichert Pachymetry” menu is selected, the following options are shown.
System Menu Screen (Continued) Delete Database Tapping Delete Database will erase the entire database from memory, and delete all examination data. Do not perform this action if the Pachymeter’s database has not been archived by hotsyncing, unless the data is no longer needed. You may delete individual entries by entering the View Database page. Select the individual examination you would like to delete by tapping on the examination line. The examination line will be highlighted. Tap the Delete button.
System Menu Screen (Continued) IOP Reference List This screen displays the IOP Formula References screen and lists the journal articles from which the reference equations for the above pre-programmed formulas are taken. About Pachymeter This screen shows the software and firmware versions, and the device serial number. HotSync the IOPac Archive Database The database will be backed up onto a PC during each HotSync (as described in the Palm operating manual on the supplied CD ROM, and in the Appendix A).
Printer Data Printing the Examination Information Select an examination file by tapping on the examination name and make sure the printer is powered on. Point the Pachymeter infrared (IR) port towards the printer’s IR port and then tap Print. The Pachymeter’s IR port has a dispersion angle of about 90 degrees side to side and must be pointing at and within about 3 feet (1m) of the printer’s IR port. NOTE: A Canon PIXMA iP-90 printer should be used for best results.
Printer Data (Continued) Printing the Examination Information (Continued) Sample Refractive Examination Print-out 16012-101 Rev.
Cleaning External Cleaning WARNING: DO NOT IMMERSE THE connector OR THE main unit in ANY liquid OR DAMAGE TO THE UNIT WILL OCCUR. Clean the external surfaces of this instrument using a clean, soft cloth moistened with a mild detergent solution (1 cc of liquid dish soap to one liter of clean, filtered water (filtered below 5 microns)).
Troubleshooting Frequently Asked Questions Q: The unit will not power up. A: Always ensure the IOPac is charged sufficiently. USE ONLY THE SUPPLIED PALM CHARGER PROVIDED WITH THE UNIT, or a USB CABLE (such as the one supplied with the IOPac) CONNECTED TO A COMPUTER. We recommend a minimum charge level of 50%. The IOPac is based on a Palm handheld computer that uses a rechargeable battery to maintain stored data and programs.
Troubleshooting (Continued) Frequently Asked Questions (Continued) Q: The calibration guide hole is dirty, how should I clean it? A: Using a Q-tip or similar soft tipped device dipped in alcohol gently swab the hole. Ensure that the flat calibration surface at the bottom of the hole is clean. Be sure not to exert excess force onto the phantom while cleaning.
General Specifications The IOPac displays thickness measurements to the nearest 1 µ m, and the expected accuracy of readings is ±5 µm over the measurement range of 300 to 1000 µ m. This assumes that the actual speed of sound in the cornea corresponds with that used in the measurements. The IOPac uses a speed of 1640 m/s, which is the most commonly accepted value for corneal tissue.
General Specifications (Continued) Acoustic Output Powers Acoustic Output MI ISPTA.3 (mW/cm2) ISPPA.3 (W/cm2) Global Maximum Value 0.155±0.014 3.72±0.98 12.2±2.0 0.040±0.010 0.040±0.010 Pr.3 (MPa) 0.70±0.07 Wc (mW) Associated Acoustic Parameters fc (MHz) 20.2±1.4 20.2±1.4 20.2±1.4 zsp (cm) 0.3 0.3 0.3 x-6 0.11 0.11 y-6 0.11 0.11 Beam Dimensions (cm) PD (ms) 0.07 0.07 PRF (Hz) 4600 4600 EBD (cm) Operator Controls Az 0.2 El 0.
General Specifications (Continued) Tissue Exposure To Ultrasound Energy The ultrasound energy emitted by the IOPac is of low intensity and will have no adverse effects on the patient and/or operator. However, the operator is still cautioned to perform examinations using the principle of ALARA (As Low As Reasonably Achievable). All examinations should be done so that the patient receives as little ultrasound radiation as possible.
Appendix A – Installing IOPac Support on a Windows PC (HotSync) It is good practice to backup or “synchronize” files from the Pachymeter’s memory to a PC to prevent loss of data due to accidental deletion or unforeseen failures. To do this requires a PC with a Palm HotSync service. This includes a HotSync Manager, an Install Tool and an IOPac support folder to hold backup files uploaded from the Pachymeter.
The Install Wizard encourages the user to perform a first time HotSync operation after the software has been installed on the PC. New IOPac users should go through this exercise as a way of both verifying the User Name they entered and checking that the USB connection between the IOPac and the desktop computer is functioning correctly.
You should also select Skip on the following screen, as there is no additional software needed or recommended, and then select Quit to exit the installation program. 32 16012-101 Rev.
Appendix B - Procedures for Retiring a Full IOPac Database The IOPac Pachymeter examinations database, called P20Dbase.pdb, is designed to hold about 1000 examinations in memory. Given that there is more than 8 MB of memory available, database capacity is probably somewhat higher but it is difficult to estimate given the fact that other applications may also grow as the examinations database does.
Appendix C - Procedures for Reinstalling Missing IOPac Program Files IOPac Pachymeters come from the factory with all necessary pachymetry software pre-installed on the device. IOPac owners usually consider re-installing the software files on the Pachymeter for one of two reasons: To update to a newer IOPac version To recover files lost due to accidental deletion The IOPac comes from the factory with all necessary pachymetry software pre-installed in memory. To reinstate missing Pachymeter files: 1.
End User Software License Agreement CAREFULLY READ THE FOLLOWING TERMS AND CONDITIONS BEFORE USING THIS PRODUCT. IT CONTAINS SOFTWARE, THE USE OF WHICH IS LICENSED BY REICHERT, INC. TO YOU, THE ORIGINAL END USER, FOR YOUR USE ONLY AS SET FORTH BELOW. IF YOU DO NOT AGREE TO THE TERMS AND CONDITIONS OF THIS AGREEMENT, DO NOT USE THE SOFTWARE. USING ANY PART OF THE SOFTWARE INDICATES THAT YOU ACCEPT THESE TERMS. Software included with this product that are not products of Reichert, Inc.
Reichert Warranty This product is warranted by Reichert, Inc. against defective material and workmanship under normal use for a period of one year from the date of invoice to the original purchaser. (An authorized dealer shall not be considered an original purchaser.) Under this warranty, Reichert’s sole obligation is to repair or replace the defective part or product at Reichert’s discretion.
Notes 16012-101 Rev.
Reichert, Inc. 3362 Walden Ave Depew, NY 14043 USA Toll Free 888-849-8955 Phone: 716-686-4500 Fax: 716-686-4545 email: info@reichert.com www.reichert.com Reichert GmbH Hubertstrasse 2 D-82229 Seefeld Germany Tel: +49 8152 993530 Fax: +49 8152 993535 ISO-9001/13485 Registered May 2009 38 16012-101 Rev.
