Reichert IOPac Standard, User Manual

Page 1: ...Standard User s Guide ...

Page 2: ...hert 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 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 2 16010 101 Rev ...

Page 3: ...12 System Menu Screen 13 Check Calibration 13 About Pachymeter 14 HotSync the IOPac 14 Program Installation 14 Cleaning 15 External Cleaning 15 Probe Cleaning 15 Troubleshooting 16 Frequently Asked Questions 16 General Specifications 17 Specifications 17 Storage Conditions 17 Operating Conditions 17 Acoustic Output Powers 18 Definitions 18 Tissue Exposure To Ultrasound Energy 19 Appendix A Install...

Page 4: ...TH OR TISSUE ALWAYS STORE THE PROBE WHEN NOT BEING USED IN THE PROVIDED HOLDER TO PROTECT IT DO NOT USE THE PROBE AS A STYLUS DO NOT ATTEMPT TO USE THE IOPAC IF THERE IS ANY INDICATION THE PROBE TIP BODY OR CABLE HAS BEEN DAMAGED AND OR THEIR PHYSICAL INTEGRITY HAS BEEN COMPROMISED IF THE PROBE TIP HAS MADE CONTACT WITH ANYTHING BETWEEN APPLANATIONS REPEAT DISINFECTING PROCEDURE WARNING MEASUREMEN...

Page 5: ...ECTIVE CAP FROM THE TRANSDUCER BE CAREFUL NOT TO PULL TOO HARD LET SOME AIR UNDER THE LIP OF THE CAP BY LIFTING GENTLY WITH A FINGERNAIL AND IT SHOULD COME OFF EASILY CAUTION 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 5...

Page 6: ...f Symbols Type BF Patient applied parts are insulated Catalog Number Serial Number Attention See Instructions for use Date of Manufacture Waste of Electrical and Electronic Equipment Conformity with mandatory European Safety requirements SN ...

Page 7: ...ortant data on other media to protect against data loss Reichert Inc assumes no responsibility for any damage loss or claims which may result from the use of the IOP correction formulas or lookup table whether predefined in the software or customized by the user The use of any specific IOP correction algorithm is entirely the responsibility of the pachymeter operator IMPORTANT Please read the End ...

Page 8: ...ight corner on the IOPac screen activates the numeric keyboard Tapping ABC located on the lower left corner on the IOPac screen activates the alphabetic keyboard You can access the Graffiti help when in the main screen of the IOPac program by swiping the stylus from the bottom of the screen to the top of the screen NOTE You may adjust the screen contrast by tapping on the icon Tap to the left or r...

Page 9: ... computer via the provided USB cable and features the popular and user friendly Palm OS interface Unpacking Instructions The instrument is packaged in a shipping container to protect the instrument from damage during shipment Please read the User s Guide before operating the unit Please unpackage the instrument in the following manner 1 Open the box and remove the accessories from the foam packagi...

Page 10: ...Setup Continued Parts Identification Parts 1 Charging Power Cord 2 USB Cord 3 Power Adapters 4 IOPac Standard 5 Graffiti Labels 6 Ultrasound Probe 7 Stylus attached to the Palm 8 Manuals and Software Disks not shown 6 4 3 1 2 5 ...

Page 11: ...es after which it will shut off Data will NOT be lost if the unit shuts off automatically When turning on the instrument for the first time the main screen will appear The main screen indicates Start Measuring If the initial screen is not as indicated as below then touch the house icon at the lower left of the touch screen and then touch the IOPac icon and the screen below will be shown Power Butt...

Page 12: ...measurement acquisition early by tapping the Stop button Tapping the Cancel button will cancel measuring and bring you back to the main screen Place the tip of the probe on the center of the cornea Once the probe is perpendicular to the cornea the Pachymeter will acquire up to 8 eight measurements A successful measurement is signaled by a high tone An unsuccessful measurement caused for example by...

Page 13: ... Calibration from the pull down menu Place a drop of water Do not use ultrasonic gel on the calibration phantom tap the Calibrate button and then place the probe lightly on the calibration phantom A tone signals calibration is complete and the results of the calibration are reported next to the Phantom Standard Note The probe must be perpendicular to the calibration phantom therefore some manual a...

Page 14: ...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 ...

Page 15: ...THE PROBE TIP BODY OR CABLE HAS BEEN DAMAGED AND OR THEIR PHYSICAL INTEGRITY HAS BEEN COMPROMISED OR INJURY TO THE CORNEA MAY OCCUR CAUTION DO NOT USE THE PROBE AS A STYLUS OR DAMAGE TO THE PROBE MAY OCCUR CAUTION DO NOT STERILIZE THE PROBE USING ETO AUTOCLAVING OR IRRADIATION OR DAMAGE TO THE PROBE WILL OCCUR CAUTION IF THE PROBE TIP HAS MADE CONTACT WITH ANYTHING BETWEEN APPLANATIONS REPEAT THE ...

Page 16: ...lace a drop of artificial tears on the eye before the measurement Q What happens if I disrupt the printing by blocking the IR beam or displacing the IOPac A The IOPac is fairly tolerant of beam disruption If an object or the field of view changes and disrupts the printing readjust the IOPac to have a clear line of sight to the printer s IR port Q The Pachymeter software is hung up and won t respon...

Page 17: ...vice per FDA classification Class IIa medical device per European MDD 93 42EEC Class II medical device per Canadian MDR SOR 98 282 Measurement range 300 to 1000 µm Accuracy 5µm Overall size 170 x 90 x 40 mm Weight 200 g Probe tip diameter 2 mm Probe ultrasound frequency 20 MHz Probe geometry Angled or Straight Tip The IOPac is type BF which means that the transducer applied to the patient is isola...

Page 18: ...atial peak temporal average derived intensity Ispta is less than 100 mW cm2 Definitions ISPTA 3 derated spatial peak temporal average intensity milliwatts per square centimeter ISPPA 3 derated spatial peak pulse average intensity watts per square centimeter MI Mechanical Index pr 3 derated peak rarefactional pressure megapascals associated with the transmit pattern giving rise to the value reporte...

Page 19: ...cm2 10 23 10 22 MI unitless 0 171 0 170 Since the IOPac is a contact instrument the energy will always be attenuated by the tissue when used as recommended However since the focal length point of maximum intensity is very short 1 mm and thus penetration into the eye is limited the water values are effectively the same as the tissue values for all practical purposes If more accuracy is desired the ...

Page 20: ...dhelds and Palm Desktop software To synchronize your data connect the HotSync cable to your computer and your handheld At the heart of the IOPac Pachymeter is a Palm PDA A HotSync service running on the PC should be used regularly to backup software from the Pachymeter memory to the PC in case of loss of the Pachymeter database HotSyncing involves connecting the Pachymeter and the PC with the supp...

Page 21: ...is functioning correctly Therefore when the Synchronize your device and computer screen appears do not click Skip but connect the USB cable and follow the instructions to perform your first HotSync Note that you need to be on the Home screen of the IOPac for the HotSync button to work You can get to the Home screen from the IOPac software by tapping on the Home button which looks like a house User...

Page 22: ...22 16010 101 Rev C 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 ...

Page 23: ...tart Programs Palm menu 2 Insert the CD ROM that came with the IOPac Open the folder CD_drive IOPac Programs Select the ten files in this folder and drag them onto the Palm Quick Install window 3 Exit the Palm Quick Install program If displayed acknowledge the message saying that the file will be installed during the next HotSync 4 Perform a HotSync between the PC and the IOPac 5 After a successfu...

Page 24: ...er transfer all copies of the Software as well as the supporting documentation to the same party or destroy any such materials not transferred Except as set forth above you may not transfer or assign the Software or your rights under this License Agreement Modification reverse engineering reverse compiling or disassembly of the Software is expressly prohibited However if you are a European Union E...

Page 25: ... PATENT WARRANTY If notified promptly in writing of any action brought against the purchaser based on a claim that the instrument infringes a U S Patent Reichert will defend such action at its expense and will pay costs and damages awarded in any such action provided that Reichert shall have sole control of the defense of any such action with information and assistance at Reichert s expense for su...

Page 26: ...26 16010 101 Rev C Notes ...

Page 27: ...16010 101 Rev C 27 Notes ...

Page 28: ...e 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 ...