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Reichert IOPac Advanced, Руководство пользователя

Рейхерт IOPac Advanced - передовой прибор для измерения внутриглазного давления. Прилагается бесплатный пользовательский руководство для настройки и использования устройства. Скачать руководство можно с нашего веб-сайта. Узнайте все возможности продукта, прочитав наше подробное руководство.

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16012-101 Rev. C

3

Table Of Contents

Warnings & Cautions ............................................................................................................................................................................. 4

Symbols................................................................................................................................................................................................... 6

Explanation of Symbols ............................................................................................................................................................ 6

Introduction ............................................................................................................................................................................................ 7

Disclaimer and Limitation of Responsibility .............................................................................................................................. 7
FCC Statement ......................................................................................................................................................................... 7
Copyright .................................................................................................................................................................................. 7
User Interface ........................................................................................................................................................................... 8

IOPac Setup ............................................................................................................................................................................................ 9

Unpacking Instructions ............................................................................................................................................................. 9
Parts Identification .................................................................................................................................................................. 10

Instructions for Use.............................................................................................................................................................................. 11

Turning On and Off ................................................................................................................................................................. 11
Start Measuring Central Corneal Thickness (CCT) Measurement ......................................................................................... 12
Risk Estimate.......................................................................................................................................................................... 15
View Database........................................................................................................................................................................ 17
Using the Refractive Module................................................................................................................................................... 18

System Menu Screen ........................................................................................................................................................................... 19

Check Calibration ................................................................................................................................................................... 19
Delete Database ..................................................................................................................................................................... 20
IOP Formulas.......................................................................................................................................................................... 20
IOP Formula References ........................................................................................................................................................ 20
IOP Corrections Table ............................................................................................................................................................ 20
About Pachymeter .................................................................................................................................................................. 21

HotSync the IOPac ............................................................................................................................................................................... 21

Archive Database ................................................................................................................................................................... 21

Printer Data ........................................................................................................................................................................................... 22

Printing the Examination Information...................................................................................................................................... 22
Printing Multiple Exams at One Time ..................................................................................................................................... 22
Printing the Examination Information (Continued) .................................................................................................................. 23

Cleaning ................................................................................................................................................................................................ 24

External Cleaning ................................................................................................................................................................... 24
Probe Cleaning ....................................................................................................................................................................... 24

Troubleshooting ................................................................................................................................................................................... 25

Frequently Asked Questions................................................................................................................................................... 25

General Specifications......................................................................................................................................................................... 27

Specifications.......................................................................................................................................................................... 27
Storage Conditions ................................................................................................................................................................. 27
Operating Conditions .............................................................................................................................................................. 27
Acoustic Output Powers ......................................................................................................................................................... 28
Definitions ............................................................................................................................................................................... 28
Tissue Exposure To Ultrasound Energy ................................................................................................................................. 29

Appendix A – Installing IOPac Support on a Windows PC (HotSync)............................................................................................. 30

Appendix B - Procedures for Retiring a Full IOPac Database.......................................................................................................... 33

Appendix C - Procedures for Reinstalling Missing IOPac Program Files....................................................................................... 34

End User Software License Agreement ............................................................................................................................................. 35

Reichert Warranty................................................................................................................................................................................. 36

Содержание IOPac Advanced

Страница 1: ...ADVANCED User s Guide ...

Страница 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 16012 101 Rev ...

Страница 3: ...ections Table 20 About Pachymeter 21 HotSync the IOPac 21 Archive Database 21 Printer Data 22 Printing the Examination Information 22 Printing Multiple Exams at One Time 22 Printing the Examination Information Continued 23 Cleaning 24 External Cleaning 24 Probe Cleaning 24 Troubleshooting 25 Frequently Asked Questions 25 General Specifications 27 Specifications 27 Storage Conditions 27 Operating C...

Страница 4: ...fecting procedure WARNING Measurements should not be attempted when ocular integrity is questionable The handheld transducer must touch the eye during operation Consequently the operator needs to exhibit care in manipulating the transducer Force should not be exerted against the eye the transducer tip only needs to lightly touch the cornea WARNING To ensure patient isolation from high electrical p...

Страница 5: ...ecommend 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 Like similar computers if the battery becomes too drained it will not be able to function At 40 battery level the IOPac software application will not start and at 20 the IOPac will not power on until it has been charged To ensure the IOPac is al...

Страница 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 ...

Страница 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 ...

Страница 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...

Страница 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...

Страница 10: ...Setup Continued Parts Identification 1 2 3 4 5 6 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 ...

Страница 11: ... 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 When turning on the instrument for the first time the main screen will appear From the main screen you can select from Start Measuring Risk Estimate View Database or access secondary functions like calibration Power Button Stylus ...

Страница 12: ...a moisturizing drop may also be used Entering a New Examination On the start up screen Tap Start Measuring Note The buttons are laid out where possible to facilitate tapping with your fingers For data entry the stylus is the recommended method Examination Registry Screen Tap on Operators located on the upper right side of the screen From the pull down menu select an existing operator or add a new ...

Страница 13: ...will acquire up to 8 eight measurements A successful measurement is signaled by a high tone An unsuccessful measurement caused for example by the probe not being placed correctly is signaled by a lower pitched tone After a set of measurements is made the eye selection will automatically switch and will be highlighted in blue To change selection tap on the appropriate column box to select the left ...

Страница 14: ...rection 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 Enter the patient s tonometry readings using the Graffiti interface or the internal keyboard Once tonometry information is entered tap Calculate The Adjusted IOP will be calculated according to the formula you choose Tap Return to g...

Страница 15: ...re all patient details are manually entered When using the calculator during an exam select Glaucoma Risk Calculator from the menu at the top of the screen If an average OD and OS CCT has just been calculated these values will be shown in the Avg OS OD CCT data field on the Risk Calculator page The remaining data may be entered using the Graffiti interface at the bottom of the display Tap Calculat...

Страница 16: ...s entered automatically when using the current exam measurement or a patient file from the database It must be entered manually when using the calculator in stand alone mode Units are µm Vertical CD Ratio Vertical Cup Disc Ratio This value must be entered manually in all cases Pattern S D Pattern Standard Deviation This value is entered manually in all cases from a visual field tester e g Perimete...

Страница 17: ...ent You can differentiate Refractive from CCT examination records by looking at the REF REF tags in the OD OS column used for Refractive exams CCT examination records show mean values in this column When the examination details appear you can re select data in the examination file modify patient information and do IOP corrections If changes are made you will be prompted to either ignore those chan...

Страница 18: ...e around the selected zone being measured will be highlighted in red Place the tip of the probe on the corresponding point on the patient s eye Once the probe is perpendicular to the eye surface the pachymeter will automatically acquire up to 5 measurements You will hear a beeping sound to let you know the pachymeter is taking measurements After a particular zone has been completed the values in m...

Страница 19: ...eft corner of the IOPac screen with the stylus Select Check 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 Note The probe must be perpendicular to the calibration p...

Страница 20: ...ASE PDB this is the archived file should be moved to a secure location such as a floppy disk or a CD R It is recommended that 2 copies be kept The full examination database should then be deleted from the IOPac IOP Formulas Formulas 1 through 4 are all of the form Corrected IOP Uncorrected IOP Correction Measured Corneal Thickness Normal Corneal Thickness Each is taken from a published journal art...

Страница 21: ...las 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 It is recommended that you back up the exams database file P20Dbase every week and archive a copy in a s...

Страница 22: ...esults Alternatively an IR to parallel printer adapter such as the ACTiSYS ACT IR100N can be used Other printers or adapters have not been tested and correct results cannot be assured The ACTiSYS adapter can be purchased from ACTiSYS web site at www actisys com Always confirm the printed record with the electronic data on the IOPac before using the data for diagnostic purposes Printing Multiple Ex...

Страница 23: ...16012 101 Rev C 23 Printer Data Continued Printing the Examination Information Continued Sample Refractive Examination Print out ...

Страница 24: ...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 ...

Страница 25: ...e easily read on a PC The HotSync operation is only for backup purposes New PC software application has recently been released that allows you to view the contents of an archived examinations database view and print details of individual records and merge archived databases into a single database This Database Manager program for Windows 2000 and Windows XP may be purchased separately from your lo...

Страница 26: ...ntly 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 Q Why does the unit display a reading when not in contact with the patient s eye A If the tip of the probe is wet the unit will measure the thickness of the drop of water on the tip To avoid this ensure the tip is dry after cleaning or dis...

Страница 27: ...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...

Страница 28: ...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...

Страница 29: ...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 ...

Страница 30: ...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...

Страница 31: ...ning 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 Users should s...

Страница 32: ...32 16012 101 Rev C 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 ...

Страница 33: ...Install the Palm Desktop program on a Windows PC shortly after receiving the IOPac Pachymeter 2 Connect the IOPac to one of the PC s USB ports using the supplied cable 3 Make sure that the HotSync Manager is running look for its icon in the Windows Tool Tray at the lower right corner of the monitor If the HotSync Manager service is not already running start it from Start Programs Palm HotSync Mana...

Страница 34: ...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...

Страница 35: ...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...

Страница 36: ... 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...

Страница 37: ...16012 101 Rev C 37 Notes ...

Страница 38: ...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 ...

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