Reichert IOPac Standard User manual

Standard
User’s Guide
®

2009 Reichert, Inc. Reichertis a registered trademark of Reichert, Inc.
The information contained in this document was accurateat time of publication. Specifications subject to change without
notice. Reichert, Inc. reserves the right to make changes in the product describedin this manual withoutnotice and
without incorporating thosechangesin 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, orotherwise, without the prior written permissionof Reichert, Inc.
2
16010-101 Rev. C

16010-101 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
Parts:...................................................................................................................................................................................... 10
Instructions for Use.............................................................................................................................................................................. 11
Turning On and Off................................................................................................................................................................. 11
Start Measuring Central Corneal Thickness (CCT) Measurement......................................................................................... 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 – Installing IOPac Support on a Windows PC (HotSync)............................................................................................. 20
Appendix B - Procedures forReinstalling Missing IOPac Program Files....................................................................................... 23
End User Software License Agreement............................................................................................................................................. 24
Reichert Warranty................................................................................................................................................................................. 25

416010-101 Rev. C
Warnings & Cautions
Reichert, Inc. (Reichert) is not responsible for thesafety and reliability ofthis instrument when:
• Assembly,disassembly, repair, ormodification 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. ONLY
OPERATORS TRAINED IN THE USE OF OPHTHALMIC INSTRUMENTS THAT CONTACT THE EYE SHOULD USE
THIS DEVICE. REICHERT, INC. CANNOT BE HELD RESPONSIBLE FOR ANY DAMAGE OR INJURY THAT
RESULTS FROM A FAILURE TO FOLLOW DIRECTIONS IN THE USER’S MANUAL. PLEASE ENSURE THAT
YOU ARE ENTIRELY FAMILIAR WITH THE CORRECT PROCEDURES FOR OPERATING THE INSTRUMENT
BEFORE USE!
WARNING: IN ORDER TO PREVENT PATIENT-TO-PATIENT TRANSFER OF INFECTION, AFTER EACH USE DISINFECT THE
PROBE FOLLOWING ACCEPTED LOCAL CLINICAL PROCEDURES REGARDING THE USE OF
DISINFECTANTS. ANY CLINICALLY APPROVED CHEMICAL DISINFECTANT CAN BE USED. AFTER EACH
PATIENT, WE RECOMMEND WIPING THE PROBE WITH A COTTON SWAB SOAKED IN 70% ISOPROPYL
ALCOHOL, AND THEN IMMERSING THE PROBE TIP FOR 10 MINUTES IN 70% ISOPROPYL ALCOHOL OR AN
EQUIVALENT LOCALLY APPROVED DISINFECTANT. THE PROBE AND CABLE MAY BE IMMERSED IN
LIQUID, BUT THE CONNECTOR AND MAIN UNIT CANNOT BE IMMERSED IN ANY LIQUID. DO NOT STERILIZE
THE PROBE USING ETO, AUTOCLAVING, OR IRRADIATION. AFTER CLEANING, RINSE THE END OF THE
PROBE THOROUGHLY WITH STERILE DISTILLED WATER. DRY THE PROBE WITH A LINT FREE CLOTH 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: 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 POTENTIAL, DO NOT USE THE IOPAC ON A
PATIENT WHEN THE INSTRUMENT IS CHARGING. IOPAC CHARGING MUST ONLY TAKE PLACE AT A
DISTANCE OF AT LEAST 1.5 M FROM THE PATIENT.
WARNING: DO NOT USE ANY TRANSDUCER PROBE ON THE IOPAC OTHER THAN THE ONES SUPPLIED EXPRESSLY
FOR THIS PURPOSE. OTHER TRANSDUCERS MAY NOT GENERATE ACCEPTABLY LOW ULTRASOUND
ENERGY LEVELS.
WARNING: CARE SHOULD BE EXERCISED WHEN HANDLING THE TRANSDUCER, TO AVOID BREAKING THE TIP AT THE
ELBOW (ANGLED TRANSDUCERS ONLY). EXTREME FORCE SHOULD NEVER BE APPLIED WHEN
REMOVING OR STORING THE TRANSDUCER IN ITS HOLDING CLIP.
CAUTION: AN INSTRUCTION THAT DRAWS ATTENTION TO THE RISK OF DAMAGE TO THE PRODUCT.
CAUTION: DO NOT INSTALL ANY ADDITIONAL SOFTWARE. ALTHOUGH THIS PRODUCT USES THE PALM OPERATING
SYSTEM, IT IS A DEDICATED PACHYMETER AND MUST NOT BE USED FOR ANY OTHER PURPOSE. THE
USE OF THIS DEVICE WITH ANY SOFTWARE OTHER THAN THAT SUPPLIED WITH THE PACHYMETER HAS
NOT BEEN VALIDATED. THE MANUFACTURER OR DISTRIBUTOR CANNOT BE HELD RESPONSIBLE FOR
ANY FAILURES RESULTING FROM THE USE OF UNAUTHORIZED SOFTWARE.

16010-101 Rev. C 5
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. HOWEVER, BY LIMITING SCANS
TO THE MINIMUM NEEDED TO OBTAIN DESIRED DIAGNOSTIC INFORMATION, THE PATIENT’S EXPOSURE
TO ULTRASOUND ENERGY WILL BE MINIMIZED. PREPARING THE PATIENT BEFORE SCANNING BY
ADVISING HIM OR HER ON WHAT TO EXPECT IS ONE WAY OF REDUCING THE NUMBER OF SCANS THAT
NEED TO BE 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.
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 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 ALWAYS READY FOR USE, A GOOD GUIDELINE IS TO CHARGE IT OVERNIGHT AT LEAST
WEEKLY AND TO LEAVE IT ATTACHED TO A CHARGER WHEN NOT IN USE FOR LONGER PERIODS.
CAUTION: PROTECT YOUR DATA BY ARCHIVING IT. GOOD PRACTICE IS TO PERFORM REGULAR HOT SYNC
OPERATIONS AS DESCRIBED IN APPENDIX A OF THIS MANUAL TO ARCHIVE YOUR DATA IN A SECURE
LOCATION ON YOUR PC.
CAUTION: CHANGES OR MODIFICATIONS TO THIS EQUIPMENT, NOT EXPRESSLY APPROVED BY THE
MANUFACTURER, COULD VOID THE WARRANTY AND THE USER'S AUTHORITY TO OPERATE THE
EQUIPMENT.

616010-101 Rev. C
Symbols
Explanation of Symbols
Type BF Patient-appliedparts 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

16010-101 Rev. C 7
Introduction
Congratulationson 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. dealeror contact our Customer Service department directly at:
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Disclaimer and Limitation of Responsibility
Reichert, Inc. assumes no responsibility for any damage, loss or claims which may result from a failure to follow
the instructions contained in this Technical Manual. Reichert, Inc. assumes no responsibility for any damage or
loss caused by deletion of data as result of malfunction, dead battery, or repairs. Be sure to make copies of all
important 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 User Software License Agreement with this product before using the accompanying
software program. Using any part of the software indicates that you accept the terms of the End User Software License
Agreement
FCC Statement
This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference and (2) this device must accept any interference received, including
interference that may cause undesired operation.
Copyright
Graffiti®, HotSync®, the Palm®logo, and Palm OS®are registered trademarks, and Palm™ and Palm Powered™ are
trademarks of Palm, Inc. Canon PIXMA iP-90 (printer) is a trademark of CanonCorporation.
IOPac is a registered trademarkof Reichert, Inc.

816010-101 Rev. C
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 thatis supplied with the
IOPac.
Data can be entered by eitherusing the Graffiti interface or theinternal keyboard. Tapping 123 located on the lower right
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 tothe top of thescreen.
NOTE: You may adjust the screen contrast by tapping on the icon. Tap to the left or right of the slider to adjust the
contrast in small increments or drag the slider to change the contrastin large increments.
Contrast
Numeric Keyboard
Alphabetic Keyboard
Text Entry Area
Number Entry Area
Time and Date

16010-101 Rev. C 9
IOPac Setup
Great care has been taken to deliver your new IOPac Standard pachymeter safely to you. The container and packaging
was specially designed totransport this unit. Please retain thispackaging for any future use if transportation is required.
This IOPac Pachymeter is intended for measuring corneal thickness of the human eyeusing ultrasound technology. It
features a 20 MHz probe capable of an accuracyof ±5 µm. The measurement takes 1– 2 seconds. A successful
measurementis announced by a high-pitch tone. An unsuccessful measurement (caused, for example, by the probe not
being placed correctly) isannounced by alower pitch tone. The IOPac incorporatesmultiple corrected Intraocular
Pressure (IOP) formulas, as well as the ability for the end user to create their owncustom IOP formula. The IOPac is a
portable battery operated device, can store approximately 1000 exams internally and has printing capability viainfrared to
an optional printer. The IOPac can also backup examination information toyour computer via theprovided USB cable
and features the popular and userfriendly Palm OS interface.
Unpacking Instructions
The instrument ispackaged in a shipping container to protect the
instrument from damage duringshipment. Please read the User’s
Guide before operating the unit.
Please unpackagethe instrument in the following manner:
1. Open the box and remove the accessories from the foam
packaging. Refer to the figure “IOPac inBox.”
•IOPac Standard
•Ultrasound Probe
•Charging Power Cord
•Power Adapters
•USB Cord
•Palm Stylus
•Graffiti Labels
•Palm Software
•User’s Guide
2. Plug the Ultrasound Probe into the back ofthe IOPac. Refer
to the figure “IOPac Probe Connection.”
3. Plug the Power Adapter into the charging port and let it charge
the IOPac’s internal battery for12 uninterrupted hours. Refer
to the figure “IOPac Charging Port Connection.”
Note: The battery icon at the topof the Home screen indicates how
fully charged thebattery is. When the battery icon is all blue it
is fully charged.
Note: At a battery level of 40% and lower the IOPac software
application will not start, and at 20% the IOPac will not power on
until it has been charged.
IOPac in Box
IOPac Probe Connection
Probe
Charging Port
IOPac Charging Port Connection

10 16010-101 Rev. C
IOPac 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

16010-101 Rev. C 11
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 to3 minutes after which it will shut off. Data will NOT be lost if the unit shuts off automatically.
When turning on the instrument forthe 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 touchscreen and then touchthe IOPac icon and the screen below will be shown.
Power Button
Stylus

12 16010-101 Rev. C
Instructions for Use (Continued)
Start Measuring Central Corneal Thickness (CCT) Measurement
Preparation of the Patient
The patient shouldbe 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 gentlycontact their eye. A drop of ocular anesthetic should be placed in the eye oreyes that are
going to be measured. If the patient has dry eyes, a moisturizing dropmay also be used.
Acquiring a Measurement
On the start up screen, Tap: Start Measuring.
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) andleft (OS) eyes. The instrument will default to the right(OD) eye.
You can switchthe eye that you want tomeasure by tapping either theOD or OS box at the top of the screen.
To start measuring, tap: Start. You will hear a beeping sound to let you know the
Pachymeter is taking measurements. You may stop 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 thecenter of the cornea. Once the probe is
perpendicular to thecornea the Pachymeter will acquire up to8 (eight)
measurements. A successful measurement issignaled by a high tone. An
unsuccessfulmeasurement (caused, for example, by the probe not being placed
correctly) is signaled by a lower pitched tone.
After a set of measurements ismade the eye selection will
automatically switchand will be highlighted in blue. To
change selection, tap on theappropriate column box to
select the left or right eye and follow the above procedure.
A mean thickness in microns and standard deviation
(shown in brackets) will appear after completion of the
measurements.
Review the measurements ofboth eyes. You can eliminate any measurement
from the mean and standard deviation calculations by tapping on the check
mark in the box next to the measurement reading thatyou want to eliminate.
The mean and standard deviation will update accordingly.
To retake a measurement, select the eye (OD or OS) that you want to retake,
and tap the Start button.

16010-101 Rev. C 13
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 selectionare indicated below:
•Check Calibration
•About Pachymeter
Check Calibration
It is recommended that youcheck the calibration approximately every 14 days.
From the main screen, tap Reichert Pachymeter located on the upper leftcorner of the IOPac screen with the stylus.
Select: Check Calibration fromthe 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 signalscalibration is complete and the
results of the calibration arereported next to the “Phantom Standard”
Note: The probe must be perpendicular to thecalibration phantom
therefore some manual adjustment of probealignment may be
required for the IOPac to obtain a reading. If the measured
thickness isslightly greater or less than the allowable range, try
redoing the calibration while exerting less pressure onto the
phantom. If the measured thickness consistently measures
outside of the tolerance range, please contact an authorized
Reichert dealer.

14 16010-101 Rev. C
System Menu Screen (Continued)
About Pachymeter
This screen shows the software and firmware versions, and the device serialnumber.
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 forinstalling theprogram.

16010-101 Rev. C 15
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)).
Probe Cleaning
WARNING: IN ORDER TO PREVENT PATIENT-TO-PATIENT TRANSFER OF INFECTION, AFTER EACH USE DISINFECT THE
PROBE FOLLOWING ACCEPTED LOCAL CLINICAL PROCEDURES REGARDING THE USE OF
DISINFECTANTS. ANY CLINICALLY APPROVED CHEMICAL DISINFECTANT CAN BE USED.
WARNING: 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 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
CLEANING PROCEDURE.
Clean the probe using the following steps:
1. Wipe the completeprobe with a cotton swab soakedin 70% isopropyl alcohol.
2. Immerse the probe tip for 10 minutes in 70% isopropyl alcohol or anequivalent locally approved disinfectant.
3. Rinse the end ofthe probe thoroughly withsterile distilled water.
4. Dry the probe with a clean, lint-free, cloth or tissue.
5. Store the probe in itsprovided holder on the unit when it is not in use so thatit is safely stored.

16 16010-101 Rev. C
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 levelof 50%. The IOPac is based on a Palm handheld computerthat uses a
rechargeable batteryto maintain stored data and programs. Like similarcomputers, if the battery becomes toodrained it
will not be able to function. To ensure the IOPacis always ready for use, a good guideline is tocharge it overnight at least
weekly and toleave it attached to acharger when not in use for longer periods.
Q: I have been tapping on thecornea with the probe and I cannot get measurements?
A: The IOPac has a unique design that takes multiple measurements very quickly. Just contact the cornea withthe probe
tip and hold it inplace until all 8measurements have been made. The IOPac is not designed to work by tapping.
Q: Why can’t I get a reading when I’m checking calibration?
A: Calibration normally works best by filling the phantom orifice with waterand placing the probe tip against thephantom
before initiating the measurement. Additionally, try shifting the angleof the probe during calibration; the face of probe tip
may not be lying flat on thephantom surface. For the 45 degree probe, it is oftenmore effective to holdthe probe by its
elbow.
Q: I cannot get a reading on an eye?
A: The most likely cause of this issueis a loose probe connection. Try pushingon the gold connectoron the back of the
Pachymeter. If that does not work, try unplugging itand checking that both the connector and unit are undamaged and
then reinsert the connector. Also confirm that the patient does not have dryeyes. It may be necessary to place 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 respond. What do I do?
A: In rare circumstances it is possible tocrash the Palm Operating system. To recover from a system hang, insert a
narrow blunt object such as an unfolded paperclip or toothpickinto the hole marked ‘reset’ on the back of the unit untilit
presses the reset buttonat the bottom of thehole. The Pachymeter screen should go blank followedby the Palm booting
screen. This will cause a soft reboot and yourdatabase and program should not be effected.
Q: How do I locate the Pachymeter software if it does not automatically load on startup?
A: To locate the IOPac icon, tapthe Home icon at lower-leftcorner of the screen andlook for the IOPac icon. Tap this
Home icon repeatedly tocycle through all programcategories until the IOPac icon is found. If this icon still appears to be
missing, tap theupper left corner of the Home screen toactivate the menu and select Info. Lookfor IOPac in the Info list,
scrolling down if necessary. If it does notappear in the Info list,try reloading theapplication usingthe HotSync feature.
Follow the directions in Appendix A of thisManual.
Q: The calibration guide hole isdirty, how should I clean it?
A: Using a Q-tipor similar soft tipped device dipped in alcohol gently swab the hole. Ensure that the flatcalibration
surface at the bottom of the hole is clean. Be sure not to exert excess force onto thephantom while cleaning.
Q: Why does the unit display areading when not in contact with the patient's eye?
A: If the tip of the probeis wet, the unit will measure the thicknessof the drop of water on the tip. To avoid this, ensure
the tip is dry after cleaning or disinfecting.

16010-101 Rev. C 17
General Specifications
The IOPac displays thickness measurements to the nearest 1 µm, and the expected accuracy of readings is ±5 µm over
the measurement range of 300 to1000 µm. This assumes that the actual speedof sound in thecornea 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. The accuracy of the reported measurements will be correspondingly affectedif the actual speed of sound
differs, but one should expect less than 3% variation.
Specifications
Class II medical device per FDA classification
Class IIa medical deviceper 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 isolated from the supply mains by
insulation such that the patient leakage current is less than the requirements of IEC60601-1.
The IOPac does nothave or require any potential equalization (grounding) conductor.
Storage Conditions
Temperature 5°C to 45°C
Humidity 10%-90% relative humidity, non condensing
Operating Conditions
Temperature 10°C to 35°C
Humidity 20%-80% relative humidity, non condensing

18 16010-101 Rev. C
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
Pr.3 (MPa) 0.70±0.07
Wc(mW) 0.040±0.010 0.040±0.010
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 0.11Beam Dimensions
(cm) y-6 0.11 0.11
PD (ms) 0.07 0.07
PRF (Hz) 4600 4600
Az 0.2
Associated
Acoustic
Parameters
EBD (cm)
El 0.2
Operator Controls There are no operator controls that alter the acoustic output power
Uncertaintiesin the above valuesare reported as ±1 standard deviation. The derated intensities were derived from those
measured in water based onthe measured center frequency of the acousticsignal (fc, MHz) and the distance from the
transducer to the point at which the intensity wasmeasured (d, cm) using theformula: Derated Intensity = Measured
Intensity *e-0.069*fc*d
In compliance with IEC61157the peak rarefaction acoustic pressure (pr) is less than 1 MPa; the output beam intensity
(Iob) is less than 20 mW/cm2; and the spatial-peak temporal average derived intensity (Ispta) is less than 100 mW/cm2.
Definitions
ISPTA.3 - derated spatial-peak temporal-average intensity (milliwatts persquare 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
reported under MI.
Wo- ultrasonic power (milliwatts). For the operating condition giving rise to ISPTA.3, Wois the total time-average power.
For the operating condition giving rise to ISPPA.3, Wois the ultrasonic power associated with the transmit pattern giving rise
to the ISPPA.3 value.
fc- center frequency (MHz). For MI and ISPPA.3, fc is the center frequency associated with the transmit pattern giving rise
to the global maximum value of the respective parameter.
zsp - axial distanceat which the reported parameter is measured (centimeters).
x-6, y-6 - are respectively the in-plane (azimuthal) and out-of-plane (elevational) -6 dB dimensions in the x-y plane where
zsp is found (centimeters).
PD - pulse duration (microseconds)
PRF - pulse repetition frequency (Hz)
EBD - entrance beam dimensions for the azimuthal and elevational planes (centimeters).

16010-101 Rev. C 19
General Specifications (Continued)
Tissue Exposure To Ultrasound Energy
The ultrasound energy emittedby the IOPac is of lowintensity and will have no adverse effects on the patient and/or
operator. However, the operator is still cautioned toperform examinations using the principle of ALARA (As LowAs
Reasonably Achievable). All examinations should be doneso that the patient receives as little ultrasound radiationas
possible. Do not hold the probe against the eyeor other tissue with the system activated except when making a
measurement. Do not make unnecessary measurements.
Ultrasonic Intensities
The IOPac has only one mode,and ultrasonic intensity settings are not under the control of the operator. Thus, the
values beloware the values to be expected for a typical transducer.
In Water In the Eye
I SPTA, mw/cm2 5.14 5.13
I SPPA, W/cm2 10.23 10.22
MI(unitless) 0.171 0.170
Since the IOPac is a contact instrument, the energywill always be attenuated by the tissue when used as recommended.
However, since the focal length (pointof maximum intensity)is very short (1 mm),and thus penetration into the eye is
limited, thewater values are effectively the same as the tissue values, for all practical purposes. If more accuracy is
desired, the intensity in the eye at thetransducer focus (corresponding to maximum intensity)may be calculated
according to the formula recommended by the FDA:
It=Iw x e(-0.069 x f x z)
where It is the estimated in situ intensity, Iw is themeasured intensity in water atthe focus of the transducer, f is the
ultrasonic frequency, and z is the distance from the face of the probe tothe transducer focus, which is the point of
measurement (1mm). The nominal frequency of these transducers is 20 MHz. The actual frequency of aparticular
transducer may vary from this value. The tissue calculations above were done with the measured frequency of the
transducer used for the tests.

20 16010-101 Rev. C
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 holdbackup files uploaded from the Pachymeter.
New IOPac owners should generally install these services shortly after receiving their IOPac Pachymeter by running the
Palm Installation Wizard on the supplied CDand installing the Palm Desktop.
Note: Experienced users who already have a version of the Palm Desktop installed on their PC to support other
handheld devices may want to skip re-installation and simply create a new user named IOPac via the Tools Users…
menu item.
Once the Palm Desktop software is installed, files may be transferred between the PC and the IOPac using HotSyncing.
What is HotSyncing
Users that haveused Palm handheld devices (PDAs) will likely already be familiar with the process of ‘hotsyncing’.
Palm defines this as:
“the ability to synchronize data between one or more Palm OS Handhelds and Palm Desktop software. To synchronize
your data connect the HotSynccable 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 PCin case of loss of the Pachymeter database.
HotSyncinginvolvesconnectingthe Pachymeter and the PC with the supplied USB cable, tapping the HotSync
icon on the
Pachymeter and waiting while files on the
Pachymeter are automatically synchronized with those
on the PC.
Installing HotSync Support on the PC
On newer Windows machines, the Palm installation autorun program will start automatically when the installation CD is
put into the CDdrive. If this doesnot occur, simply use Explorer to open the CD and click on autorun.exe – then ‘Click To
Install’.
Proceed through the license acceptance screen.
When prompted for the installation location, it is best to
accept the default C:\Program Files\Palm folder as this
is the one referred toin the instructionsin this manual.
It is important to select the correct user name when
asked. All IOPac Pachymeters have the user name
IOPac. Either select or create this as the user name
when prompted for auser name by the Install Wizard.
Then select the “Synchronize your handheld with Palm Desktop software” option, inthe next screen.
- Continued on thenext page -