® Standard 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.
CAUTION: THE IOPAC IS A PRECISION ULTRASOUND-MEASURING INSTRUMENT. PROTECT THE INSTRUMENT AGAINST DUST AND MOISTURE, AND AVOID PHYSICAL SHOCKS AND STRONG FORCES. DO NOT EXERT EXCESS PRESSURE ONTO THE SCREEN. CAUTION: IT IS PRUDENT TO MINIMIZE THE PATIENT’S EXPOSURE TO ULTRASOUND ENERGY TO A LEVEL AS LOW AS REASONABLY ACHIEVABLE (ALARA). WITH THE IOPAC, THERE ARE NO ADJUSTMENTS THAT ALTER THE AMOUNT OF ULTRASOUND ENERGY EMITTED BY THE TRANSDUCER.
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 16010-101 Rev.
Introduction Congratulations on your purchase of the IOPac Standard 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 Standard 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 1 5 4 2 6 3 Parts: 1. Charging Power Cord 2. 3. USB Cord Power Adapters 4. IOPac Standard 5. Graffiti Labels 6. Ultrasound Probe 7. Stylus (attached to the Palm) 8. Manuals and Software Disks (not shown) 10 16010-101 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. The main screen indicates Start Measuring.
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.
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. The details of each menu selection are indicated below: • • Check Calibration About Pachymeter Check Calibration It is recommended that you check the calibration approximately every 14 days.
System Menu Screen (Continued) About Pachymeter This screen shows the software and firmware versions, and the device serial number. HotSync the IOPac Program Installation The Pachymeter software can be re-installed using the HotSync (as described in the Palm operating manual on the supplied CD ROM, and in the Appendix A) utility of the Palm. Refer to Appendix B for installing the program. 14 16010-101 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.
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.
Appendix A (Continued) 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.
Appendix A (Continued) 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. 22 16010-101 Rev.
Appendix B - 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.
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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 28 16010-101 Rev.
