Keeler PachPen IFU-24-5100 User manual

PachPen
User’s guide
IFU-24-5100 REV-C

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Federal law restricts this device to sale by or on the order of a physician.
Federal communications commission (FCC) unintentional emitter per FCC part 15
This device has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC rules. These limits are designed to provide
reasonable protection against harmful interference in an oce installation. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions in the user’s guide, may cause harmful
interference to radio or television reception. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
interference to radio or television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
•Reorient or relocate the receiving antenna
•Increase the separation between the equipment and receiver
• Connect the equipment to an outlet on a different circuit than the receiver is
connected to
•Consult Keeler or an experienced radio/TV technician for help
This device complies with Part 15 of the FCC rules. Operation of this product 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.
Caution: Changes or modications not expressly approved by Keeler could void the
FCC compliance and negate your authority to operate the product.
The PachPen is manufactured and trademarked by:
Keeler
3222 Phoenixville Pike, Bldg.50
Malvern, PA 19355 USA
Toll Free [phone]
Phone [phone]
Fax [phone]

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Chapter 1: Introduction 1
PachPen overview 1
Features 1
Measurements 2
About this manual 2
Chapter 2: Safety 3
Safety information 3
Safety issues to consider when using the PachPen 3
Indications for use 3
Battery disposal 3
Symbol denitions for the PachPen 4
Safety precautions 5
Disinfection and cleaning 5
Cleaning procedure at point of use 5
Disinfection of the probe with alcohol 5
High-level disinfection of the probe 6
Warnings 6
Electrical hazard and safety 6
Avoiding equipment damage 6
Avoiding electromagnetic and other interference 7
Chapter 3: Getting started 8
Overview 8
Unpacking instructions 8
Accessories included with the PachPen 8
Battery specication and installation 8
Battery specication 8
Battery installation 8
Instructions for use 9
Initial PachPen pachymeter setup 9
Basic operation 10
How to power on the PachPen 10
How to start a new patient 10
How to take a measurement 10
How to perform a calculation 11
Chapter 4: Maintenance, storage & troubleshooting 13
General maintenance 13
Maintenance and cleaning 13
Storage 13
Troubleshooting 14
Table of contents

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Chapter 5: Specications 15
Overview 15
Physical specications 15
Environmental specications 15
Measurement accuracy 16
Operating modes 16
Acoustic output 17
Chapter 6: Warranty & repairs 19
Warranty 19
Product returns 19
Service and repair 19
All other returns 19
Nonreturnable merchandise 20
Replacement parts 20

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List of gures
Figure 1.1 - PachPen pachymeter 1
Figure 3.1 - PachPen unpacked 8
Figure 3.2 - Battery insertion 9
Figure 3.3 - Action control buttons and LCD 9
Figure 3.4 - Speed of sound screen 10
Figure 3.5 - Measurement screen 10
Figure 3.6 - Measurement screen starting new patient 11
Figure 3.7 - True IOP screen 11
Table 3.1 - IOP correction values 12
Table 4.1 - PachPen troubleshooting information 14
Table 5.1 - PachPen physical specications 15
Table 5.2 - Environmental specications 16
Table 5.3 - Measurement accuracy 16
Table 5.4 - Measurement accuracy 16
Table 5.5 - Acoustic output reporting table for track 1 non-autoscanning mode 17
Table 5.6 - Guidance and manufacturer’s declaration - electromagnetic emissions 17
Table 5.7 - Guidance and manufacturer’s declaration - electromagnetic immunity 18
Table 6.1 - Keeler replacement parts 20

Keeler AccuPen user’s guide
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Chapter 1: Introduction
1. Introduction
PachPen overview
The Keeler PachPen pictured below has all the features that make it easy to obtain
extreme accuracy and improved patient outcomes.
Figure 1.1 - PachPen pachymeter
Features
The PachPen is designed for easy access to all screens and functions.
The easy use of the control buttons and straightforward graphical user interface guide
you through every operation.
What you can’t see on the surface is also important. Signal acquisition and processing
helps ensure accurate measurements. Reliable design and ecient manufacturing
provide help with cost management, and upgradeable software protects your
investment.
The PachPen provides the following general features:
• Multi-segmented high-resolution LCD screen with control buttons to provide an
intuitive user interface
• Long-lasting lithium battery power source
•18.4 cm X 3.2 cm X 3.2 cm (7.25” X 1.25” X 1.25”) size, and 85 g (3 oz.) weight make
the unit very portable
• Ergonomic design that ts comfortably into the hand for fast and accurate
measurements
•Allows entry of Intraocular Pressure (IOP) and provides Corrected IOP based on
corneal thickness measurements
•The body of the PachPen is angled from the probe tip, and both the body and the
tip have sighting lines that allow easy visualization of the cornea, facilitating both
centration and perpendicularity
•Display of measured corneal thickness, entered IOP, corrected IOP, and average for all
stored measurements
•Capture and store up to nine measurements, along with the running average of all
measurements taken

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Measurements
The high accuracy of the PachPen measurements is provided by the following:
• High-resolution, real-time waveform analysis
•High-speed signal digitalization that acquires over 4,000 points per signal waveform
•Automatic gain control to acquire the optimum signal
•Highly sensitive 10.5 MHz composite probe
•20 individual signals acquired and analyzed to produce each measurement
About this manual
This manual is a guide for technicians, optometrists, and ophthalmologists who are
experienced in corneal thickness measurement techniques.
This manual is organized as follows:
Chapter 2 - Safety
Summarizes safety precautions, warnings, symbols, and terms.
Chapter 3 - Getting started
Provides assembly instructions and overview of PachPen basic operation.
Chapter 4 - Maintenance, storage & troubleshooting
Provides general maintenance, storage, and troubleshooting instructions.
Chapter 5 - Specications
Provides PachPen physical and operational specications.
Chapter 6 - Warranty & repairs
Describes PachPen warranty information and repair procedures.
After reading this manual, you will be able to set up the PachPen, take measurements,
enter and calculate corrected IOP.
Introduction

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Chapter 2: Safety
2. Safety
Safety information
The section lists:
• Specic safety precautions associated with the PachPen
•General safety precautions
Safety issues to consider when using the PachPen
The PachPen is noninvasive. The pachymeter probe touches the surface of the
anesthetized cornea during the exam process.
Indications for use
This instrument is used for measuring the corneal thickness of the eye. It is to be used
in a medical setting and only by physicians, optometrists, and technicians who are
experienced in corneal thickness measurement techniques.
Caution: General indications for use of the PachPen include on external, structurally
intact areas of the eye globe and orbit only.
Battery disposal
Follow the procedure outlined below for proper disposal of lithium batteries.
1. Guidelines for the disposal of lithium batteries are continually under review.
Waste-management companies can provide assistance in the disposal of these
cells and batteries.
2. Disposal should be done in accordance with applicable regulations, which
vary from country to country. In most countries, disposal of used batteries in
the trash is forbidden. Disposal can be done through nonprot organizations
mandated by local authorities or organized by professionals.
3. Cells and batteries should not be incinerated unless suitable procedures are
followed and appropriate precautions have been taken by qualied handlers.
Exposure of these cells to high temperatures or re can cause the cells to vent
and/or rupture.
4. Used batteries should be shipped with the same regulations as those for new
lithium/thionyl chloride batteries.
5. Keeler recommends that cells and batteries for disposal should be collected,
transported, and disposed of in a manner that will prevent short-circuit (the
terminals taped).
6. Handling of used cells and batteries should be done according to the safety
instructions of fresh cells.
7. Recycling of the cells and batteries should be done in authorized facilities,
through a licensed waste carrier. A recycler in United States is listed on the next
page.

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Disposal in Europe
The European Community (EC) has issued
two directives; 91/157/EEC and 93/86/
EEC. These directives are implemented by
each member country in a different way.
Thus, in each country, the manufacturers,
importers, and users are responsible for
the proper disposal or recycling.
In accordance with these directives, the
PachPen lithium cells do not contain
dangerous substances. The reaction
products are inorganic and do not
represent environmental hazards once the
decomposition or neutralization process
has terminated.
Disposal in the United States
Lithium batteries are neither specically
listed nor exempted from the federal
Environmental Protection Agency (EPA)
hazardous waste regulations, as conveyed
by the Resources Conservation and
Recovery Act (RCRA). The only metal of
possible concern in the cell is the lithium
metal that is not listed or characterized
as a toxic hazardous waste. Signicant
number of spent cells and batteries that
are untreated and not fully discharged are
considered as reactive hazardous waste.
Thus, hazardous waste of spent cells and
batteries can be disposed of after they
are rst neutralized through an approved
secondary treatment prior to disposal
(as required by U.S. Land Ban Restriction
of the Hazardous and Solid Waste
Amendments of 1984).
Disposal of spent batteries should be
performed by authorized, professional
disposal company that is familiar with
the requirements of the federal, state,
and local authorities regarding hazardous
materials, transportation, and waste
disposal. In any case, it is recommended
to contact the local EPA oce.
Shipping name: Waste lithium batteries
Un number: 3090
Label requirements: Miscellaneous,
hazardous waste
Disposal code: D003
Following is a battery recycler and
collector in the United States:
Battery Solutions
4930 Holtz Drive, Wixom, MI 48393
E: [email protected]
P: [phone]
W: www.batterysolutions.com
Symbol denitions for the
PachPen
Statements, graphics, and symbols listed
below are used on components of the
PachPen. Descriptions and meanings are
listed to the right of the symbols.
Type B medical
device
Disposal of product
within the EU
Attention! Consult
instruction manual
Battery
replacement
Action control
button
Safety

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Safety precautions
There are several areas in the use of the PachPen that require special attention, as they
may pose a safety threat.
The PachPen has an enclosure rated degree of protection of IP32. The enclosure
provides protection for objects larger than 2.5 mm and dripping water. In the event of a
spill contacting the unit, wipe the unit completely dry before returning it to service.
Disinfection and cleaning
Disinfection issues are conned to the Keeler probe that comes in contact with the
patient’s eye. In order to prevent the transmission of disease, refer to the OSHA and CDC
guidelines for proper control of disinfection. These guidelines are frequently updated
so be sure to contact OSHA, CDC, or your local disease control agency for the latest
information and disinfection technique.
The probe must be cleaned between patients to prevent patient-to-patient transfer
of infection. It is the user’s responsibility to ensure that the relevant standards are
maintained and that the products and procedures are effective and appropriate for
ophthalmic applications. The following information is provided for the guidance of
users, and specic products are mentioned for illustration only. Keeler does not endorse
the use of these or any other product. Products must be used in accordance with the
manufacturer’s instructions.
Cleaning procedure at point of use
1. Wear protective gloves when performing the cleaning process.
2. Use a soft cloth lightly dampened in a mild soap or compatible cleaning solution
to remove any particulate matter or body uids that remain on the probe or
cable.
3. To remove remaining particulates, rinse with a distilled water—dampened cloth
to remove soap residue, and then wipe with a dry cloth.
Disinfection of the probe with alcohol
One recommended disinfection technique is to clean the probe assemblies with 70%
isopropyl alcohol.
A 5 to 10 minute exposure is recommended. It is imperative that the alcohol be given
time to evaporate before applying a probe to a patient’s eye. Do not completely immerse
the probe or cable; only the tip of the probe should be placed in the solution.
After cleaning, rinse the end of the probe thoroughly with distilled water to remove all
traces of alcohol.
Probe surfaces should be dried with a lint-free cloth.

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High-level disinfection of the probe
If high-level disinfection is required by your facility, the probe may be cleaned using an
FDA-cleared high-level disinfectant, such as Cidex OPA activated dialdehyde solution.
If your facility is located in the EU, Mikrozid wipes are a compatible method of high-level
disinfection for Keeler probes.
Note: Be sure to follow the disinfectant manufacturer’s written protocol when using
any antibacterial solution, including high-level disinfectants.
Warnings
•Do not autoclave the probe or connectors
•Do not immerse the probe’s cables or metal connectors. Allow to dry before use.
•Do not immerse the probe tip in tap water. Use distilled water for cleaning and
disinfection.
Electrical hazard and safety
The PachPen is an electrical/electronic device. Reasonable care should be taken when
making an electrical connection and handling electrically powered devices. Avoid the
use of damaged electrical equipment. If repair or maintenance is to be performed on the
PachPen, the equipment must be turned off and the battery removed.
The device covers must not be removed except by qualied personnel. There are
no user controls inside the unit. To avoid injury, do not operate the PachPen without
protective covers.
The system is intended to operate from a 3.6 V lithium battery.
Warning! Before each patient procedure, inspect the probe to ensure that there are no
cracks in the outer shell.
Avoiding equipment damage
No peripheral equipment may be connected to the PachPen.
The PachPen provides no explosion protection from static discharge or arcing
components. Do not operate the instrument in the presence of explosive gases such as
ammable mixtures of anesthetic and air, or nitrous oxide.
Caution: Dropping the PachPen can result in damage to the housing or other parts
of the device. To prevent unwanted damage to the device, be sure to use the lanyard
provided when handling the unit.
Safety

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Warning! Operating or storing the device beyond the environmental ranges in the
specications chapter may result in erroneous readings and/or premature failure of
the device.
Avoiding electromagnetic and other interference
Do not use a cellular telephone or other device not compliant with EMC Class B
requirements, as its signals may cause the equipment to malfunction. The effect
of radio signals on medical devices is dependent on various factors and therefore
unpredictable. To avoid electromagnetic interference, the device must be installed and
operated in accordance with the user’s manual and using the components supplied by
Keeler.
Warning! The use of accessories, transducers, and cables other than those specied
by the manufacturer may result in increased emissions or decreased immunity.

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3. Getting started
Overview
The PachPen is designed to be used in multiple medical settings and can be rested on a
surface, such as a counter or desk. The PachPen requires no assembly.
Unpacking instructions
Upon receiving the PachPen:
1. Remove the PachPen pachymeter
case from the protective shipping
materials. Save the shipping
materials for use if return or repair
becomes necessary.
2. Check for missing items (accessories
listed below)
3. Visually inspect the PachPen
pachymeter for damage
Accessories included with the PachPen
1. (2) XENO 3.6V Lithium Battery
2. (1) Thumb drive containing this user’s guide
3. (1) Screwdriver
4. (1) Lanyard
5. (24) Alcohol prep pads
Note: Notify Keeler immediately if any components are missing or damaged. See
Chapter 6 of this user guide for contact information.
Battery specication and installation
The power source for the PachPen is a 3.6 V Lithium battery. The battery is included
with the PachPen and must be installed before use.
Battery specication
Use only one (1) 3.6 V, XENO model XLP-050F lithium battery.
Caution: Use only the style and type of battery specied. Using another style or type of
battery may cause damage to the product and invalidate the warranty.
Battery installation
Caution: The battery is polarized so that it only ts into the battery compartment
one way. Check to be sure that the battery is installed correctly, and do not force the
battery into place. Incorrect battery installation could cause severe damage to the
product and invalidate the warranty.
Figure 3.1 - PachPen unpacked
Chapter 3: Getting started

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To install the battery in the PachPen:
1. Locate the battery compartment (as
shown in gure 3.2) on the bottom of the
PachPen and open the compartment by
unscrewing the battery door screw. The
battery door is hinged to the bottom of
the handle and should not be removed
from the product.
2. Insert the XENO model XLP-050F lithium
battery, into the battery compartment as
shown in gure 3.2.
3. Close the battery compartment door and
screw the captive battery door screw
back into position to rmly hold the
battery compartment door in a closed
position. Do not over tighten the
screw.
Instructions for use
Initial PachPen pachymeter setup
The following steps outline the basic setup of the PachPen.
1. If the battery is not installed in the PachPen, install the battery as described in
“Battery installation” above.
2. If you wish to change the speed of sound setting for the unit, press and hold
the action control button for 2 to 3 seconds until the speed of sound screen is
shown on the LCD display. Then release the action control button and use the
up and down control buttons to set the speed of sound desired.
3. To return to the measurement screen, press and hold the up and down buttons
for 2 to 3 seconds until the measurement screen appears.
Up buttonAction control button
Down button
Figure 3.2 - Battery insertion
Figure 3.3 - Action control buttons and LCD

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Figure 3.4 - Speed of sound screen
Basic operation
The basic operation of the PachPen consists of the following steps:
1. Power on the PachPen instrument
2. Take up to nine measurements
3. Enter the measured IOP and calculate the corrected IOP for each eye
4. Record the data in the patient record
How to power on the PachPen
1. With the battery installed, the PachPen is always powered. However, after a
period of nonuse, the unit turns off sections of the electronics, including the
LCD, to conserve power.
2. To restore the unit to full power, press any control button.
3. The product information screen is briey shown, and then the measure screen
is displayed.
How to start a new patient
1. Hold the up and down control buttons on the PachPen simultaneously for 2 to 3
seconds.
2. A single beep from the instrument will indicate that all measurements, averages,
IOP entries, and calculations are set to zero.
Warning! The probe tip must be properly disinfected before taking any measurements
on a new patient.
How to take a measurement
1. Touch and hold the up and down control buttons on the PachPen
simultaneously for 2 to 3 seconds to reset all measurements, averages, and IOP
information to zero.
2. Press and release the action control button. Two high pitched chirps (beeps)
and a rotating line to the left of the average in the display indicate that the
PachPen is ready to take a reading.
3. Apply the probe to the patient’s eye.
4. The PachPen will automatically proceed to the next empty measurement if it is
available.
Getting started
Figure 3.5 - Measurement screen

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5. The PachPen will emit a high-pitched chirp (beep) when you have automatically
acquired a measurement.
6. The PachPen will emit three high-pitched chirps (beeps) when the ninth
measurement has been taken, or if the measurement time expires.
Notes
1. The PachPen can take up to nine
measurements and provide the
average of those measurements.
This average is the number used
when calculating the true intraocular
pressure (TIOP).
2. The * symbol by a measurement
indicates the reading that is furthest
away from the average.
3. You can review the measurements
taken by pressing the up and down
control buttons.
4. You can delete any measurement taken by touching and holding either the up
or down control button for several seconds (until the unit emits a high-pitched
chirp). After deleting a measurement, the unit will automatically recalculate the
average of the measurements.
How to perform a calculation
After you have completed a patient’s measurements, you can calculate the true IOP for
the patient. You can perform the calculation from the MIOP screen.
To calculate true IOP:
1. From the measurement screen, select
the MIOP screen by pressing and
holding the action control button for 2
to 3 seconds.
2. Enter the measured IOP by pressing
the up and down control buttons until
the proper measured IOP is displayed.
If you make a mistake, just reselect the
correct value.
3. The True IOP based on the average of the
measurements taken is displayed below the measured IOP.
4. Return to the measurement screen by pressing and holding the action control
button until the measurement screen appears.
Figure 3.6 - Measurement screen starting
new patient
Figure 3.7 - True IOP screen

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Getting started
Table 3.1 below provides the IOP correction values.
Table 3.1 - IOP correction values
Corneal thickness (micrometers) Correction values (mmHg)
405 7
425 6
445 5
465 4
485 3
505 2
525 1
545 0
565 -1
585 -2
605 -3
625 -4
645 -5
665 -6
685 -7
705 -8
Correction values according to corneal thickness of 545 micrometers. These correction values are modied from
the work of Doughty and Zamen. This chart was reproduced from the Review of Ophthalmology, July 2002. Leon
Herndon, MD, Duke University, Glaucoma Service, pages 88, 89, 90.

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General maintenance
As to not adversely affect electronic parts, keep the PachPen free of dust and dirt and
store it in a dry and cool place
Refer to Chapter 2 for details on sterilization, disinfection, and cleaning before doing any
sterilization, disinfection, or cleaning of the PachPen.
Caution: No abrasives or harsh cleaning solutions should be used while cleaning the
PachPen.
Note: The unit does not contain any user replaceable parts other than the battery.
Maintenance and cleaning
Clean the PachPen pachymeter by wiping everything except the tip with a clean, lint-free,
non-abrasive cloth and alcohol.
Clean the PachPen pachymeter tip by dipping only the rst ¼ inch of the tip into alcohol
or in an ultrasonic cleaner and allowing it to air-dry.
Do not drop the device. Avoid any shock or excessive vibration as this may damage the
unit.
Do not immerse the device in any uid. This will damage the electronics and invalidate
the warranty.
Note: See Chapter 2 for detailed cleaning instructions and see Chapter 3 for battery
specication and installation.
Storage
1. When not in use, the PachPen and all accessories should be placed in the
storage case.
2. If the PachPen is not to be used for an extended period of time, remove the
battery from the device.
Chapter 4: Maintenance, storage & troubleshooting
4. Maintenance, storage, &
troubleshooting

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Troubleshooting
Refer to table 4.1 for information on identifying and correcting problems that can occur
with the PachPen.
Table 4.1 - PachPen troubleshooting information
Symptom Probable cause Correction
“LOW BATT” displayed Battery is low Replace battery (see Chapter 3)
Multiple variable readings Improper technique Review measurement technique
Battery is low Replace battery (see Chapter 3)
Mechanical or electronic
damage
Arrange for repair through Keeler
technical service group (see Chapter 6)
No beep and/or no
display upon activation
Action control button not
held down long enough
Hold down action control button longer
Incorrect battery
installation
Check battery installation
Battery is low Replace battery (see Chapter 3)
Mechanical or electronic
damage
Arrange for repair through Keeler
technical service group (see Chapter 6)
No readings Improper technique Review measurement technique
Incorrect battery
installation
Check battery installation
Battery is low Replace battery (see Chapter 3)
Mechanical or electronic
damage
Arrange for repair through Keeler
technical service group (see Chapter 6)
Maintenance, storage, & troubleshooting

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Chapter 5: Specications
Overview
This section provides the physical and operational specications of the PachPen.
Physical specications
Table 5.1 below lists the physical specications of the PachPen instrument and
associated peripherals.
Table 5.1 - PachPen physical specications
Main unit
Dimensions 18.4 cm X 3.2 cm X 3.2 cm (7.25” X 1.25” X 1.25”)
Weight 85 g (3 oz.)
Display
Type Multi-segment monochrome liquid crystal display (LCD)
Size 28.6 mm (1.13”) diagonal viewable area
Frequency
Probe frequency 10.5 MHz, composite
Sample frequency 65 MHz
Safety
Meets EN 60601-1 Series electrical standards for medical equipment
Applied parts
PachPen pachymeter probe
Environmental specications
Table 5.2 on the next page lists the PachPen system operating and storage values for
temperature and humidity.
5. Specications