Reichert Tono-Pen AVIA User manual

TONO-PEN AVIA®Tonometer
User’s Guide

2 68E3892 Rev. C
©2010 Reichert, Inc.
The information contained in this document was accurate at time of publication.
Reichert, Inc. reserves the right to make changes in the product described in this manual
without notice and without incorporating those changes in any products already sold.
Federal law restricts this device to sale by or on the order of a physician.
ISO 9001/13485 Certied – Reichert products are designed and manufactured under
quality processes meeting ISO 9001/13485 requirements.
The following are registered trademarks of Reichert, Inc.
Reichert®
TONO-PEN AVIA®
TONO-PEN AVIA POWERCEL®
OCU-FILM®

68E3892 Rev. C 3
Table of Contents
Introduction 4
Warnings and Cautions 6
General Overview 8
TONO-PEN AVIA Tonometer Modes 9
TONO-PEN AVIA Tonometer Verication 10
TONO-PEN AVIA Tonometer Tones 11
Battery Pack Installation and Replacement 12
Liquid Crystal Display (User Interface) 13
TONO-PEN AVIA Tonometer Preparation 15
Verication Mode 16
Performing IOP Measurements 17
Applanation 18
Interpreting the IOP Measurement 19
Maintenance and Storage 20
Troubleshooting 22
Specications 23
Guidance & Manufacturer’s Declaration 24
Symbols 27
Customer Service Information 28
Warranty 29

4 68E3892 Rev. C
Introduction
INTENDED USE
The TONO-PEN AVIA®tonometer is intended for measuring
intraocular pressure (IOP) during routine eye examinations or
when increased intraocular pressure is suspected.
INDICATIONS FOR USE
The indications for use include measuring intraocular pressure
(IOP) for suspected glaucoma, or when increased intraocular
pressure is suspected.
CONTRAINDICATIONS
None
DEVICE DESCRIPTION
The TONO-PEN AVIA tonometer is an ergonomic, hand-held
tonometer that measures intraocular pressure. The body of the
instrument is designed to t comfortably in the user’s hand,
facilitating fast and accurate measurements. The tip of the
tonometer contains a sensor that houses a transducer assembly
which converts applied force into an electrical signal. The
electronics housed in the ergonomic TONO-PEN AVIA tonometer
body process and analyze the waveforms produced by each
applanation of the corneal surface of the eye. These are used to
produce an averaged IOP measurement. The measurement is
displayed on the Liquid Crystal Displays (LCDs).
A replaceable battery compartment houses the TONO-PEN AVIA
POWERCEL®battery pack, consisting of two Lithium Manganese
Dioxide batteries.

68E3892 Rev. C 5
Introduction (continued)
FEATURES
The TONO-PEN AVIA tonometer has the following features:
Easy to use - IOP can be measured reliably by medical•
professionals.
Portable - The TONO-PEN AVIA tonometer weighs just•
71 g (2.4 oz) and is battery operated.
Accurate - The measurements from the TONO-PEN AVIA•
tonometer correlate strongly with Goldmann applanation
tonometry and direct measurements of IOP.
Versatile - The TONO-PEN AVIA tonometer may be•
used easily with the patient in any position, making the
instrument suitable for the ofce, in glaucoma clinics,
at the hospital bedside, and in remote locations.
This User’s Guide is designed as a training and reference manual
for operation, maintenance, and troubleshooting. We recommend
that you read it carefully prior to use and follow the instructions in
the guide to ensure optimum performance of your new instrument.
If used properly, the TONO-PEN AVIA tonometer will provide you
with fast, accurate and reliable measurements for many years.
Please retain this manual for future reference and to share with
other users. Additional copies can be obtained from the Reichert
Customer Service Department. Contact information is provided at
the end of this guide.

6 68E3892 Rev. C
Warnings and Cautions
WARNING: An instruction that draws attention to risk of injury or death.
CAUTION: An instruction that draws attention to the risk of damage to
the product.
WARNING: Do not use the TONO-PEN AVIA tonometer on a patient without
an OCU-FILM®tip cover or inaccurate readings may be obtained.
WARNING: Do not use the TONO-PEN AVIA tonometer on a patient without
an OCU-FILM tip cover or abrasions of the cornea may occur.
WARNING: Do not use an OCU-FILM tip cover for more than one
patient to help prevent cross contamination.
WARNING: Do not use the TONO-PEN AVIA tonometer if the sensor is
cracked, chipped or shows any irregularity of the surface, to prevent patient
injury, and/or inaccurate readings.
WARNING: Do not use excessive pressure during applanation or eye injury
may occur.
WARNING: The corneal surface needs only to be momentarily contacted,
indentation or additional pressure after the audio “chirp” tone is heard is not
required and may lead to damage to the eye.
WARNING: OCU-FILM tip covers contain natural latex which may cause
allergic reactions. Question patients about allergies to latex before measuring
them with the TONO-PEN AVIA tonometer.
CAUTION: Do not use the TONO-PEN AVIA tonometer without an
OCU-FILM tip cover to prevent damage to the sensor.
CAUTION: Do not touch the sensor without an OCU-FILM tip cover applied
or damage to the sensor and transducer assembly may result.
CAUTION: Do not bump, jar or drop the device, or damage to the electronics
may occur.

68E3892 Rev. C 7
Warnings and Cautions (continued)
CAUTION: Do not immerse the TONO-PEN AVIA tonometer in uids
or damage to the electronics may occur.
CAUTION: Do not attempt to sterilize the TONO-PEN AVIA tonometer
or damage to the electronics may occur.
CAUTION: Do not attempt to modify the TONO-PEN AVIA tonometer or the
TONO-PEN AVIA POWERCEL battery pack or damage to the device may occur.
CAUTION: Do not store the TONO-PEN AVIA tonometer without an
OCU-FILM tip cover or debris may enter the sensor and transducer
assembly and cause malfunctions.
CAUTION: The TONO-PEN AVIA tonometer should not be used adjacent to
or stacked with other equipment. If adjacent or stacked use is necessary, the
TONO-PEN AVIA tonometer should be observed to verify normal operation in
the conguration in which it will be used.
CAUTION: Medical Electrical Equipment needs special precautions regarding
EMC and needs to be installed and put into service according to the EMC
information provided in this guide. Portable and Mobile RF communications
equipment can affect Medical Electrical Equipment.
CAUTION: Electromagnetic interference from other devices may affect this
instrument. If interference is present, turn off other electronic devices, or
remove them from the immediate area while operating this instrument.
TONO-PEN AVIA POWERCEL BATTERY PACK
CAUTION: Do not expose to high temperatures (>70°C / >158°F).
CAUTION: Do not attempt to recharge.
CAUTION: Do not disassemble.
WARNING: Do not carry the TONO-PEN AVIA POWERCEL battery pack
in a pocket, or close to your person, as a burn injury may result.

8 68E3892 Rev. C
A
B
F
C
D
E
General Overview
PRIMARY COMPONENTS AND CONTROLS
Tip – location of sensor A.
Transducer Assembly - housing for sensorB.
LCD - displays the IOP in mmHg, number of applanationsC.
collected, statistical condence indicator, and battery
life status
LED - green light on in Applanation Mode.D.
Power Supply - TONO-PEN AVIA POWERCELE.
battery pack
Activation Button - Applanation Mode select button.F.
Figure 1. Key Features

68E3892 Rev. C 9
TONO-PEN AVIA Tonometer Modes
POWER UP MODE
Pressing the activation button initiates the battery life, LCD,
sensor, and electronic self-test. A successful power-up puts the
device automatically into applanation mode.
APPLANATION MODE
A 15 second interval within which the user should complete the 10
applanations needed to acquire an IOP value. During applanation
mode, the LCD will display the number of applanations collected.
After 10 applanations are collected, the LCD will display the IOP
along with a statistical condence indicator. After 25 seconds,
the device will automatically go into a sleep mode. If the activation
button is pressed again the data will be lost and the unit will be
ready to start another measurement sequence.
VERIFICATION MODE
Pressing and holding the activation button for 5 seconds initiates
an electronic self test mode. See “TONO-PEN AVIA Tonometer
Verication” section for details.
SLEEP MODE
A power-saving mode automatically activated after 25 seconds
of non-use. Pressing the activation button will initiate a power-up
mode.

10 68E3892 Rev. C
TONO-PEN AVIA Tonometer Verication
If suspect readings are observed, a verication test should be
performed. This will ensure that the sensor and electronics are
performing correctly.
VERIFICATION
Hold the TONO-PEN AVIA tonometer with the sensor end•
pointing down towards the oor.
Press and hold the activation button for 5 seconds -•
a beep will sound at one second intervals.
At the end of the 5 second button hold, the display will•
show “dn”.
Keep the pen vertical, with the sensor tip pointing down•
towards the oor, for a total of 15 seconds.
At the end of this period, a beep will sound and the display•
will show “UP”.
Immediately point the sensor tip straight up and wait for•
the next beep (within 3 seconds).
A properly functioning TONO-PEN AVIA tonometer will•
display “Pass”. Pressing the activation button will now put
the device into Applanation Mode.
Verication test will need to be repeated if the display •
shows “Fail”. A single press of the Activation button will
re-start the verication test.
Note: the TONO-PEN AVIA tonometer will
remain in the Verication mode until it passes
verication test.
The most common cause for failure is debris around the•
sensor tip. Follow the instructions for cleaning the tip in
the “Maintenance & Storage” section before re-performing
the verication test.
If this is unsuccessful, please contact the Reichert•
Technical Service Department.

68E3892 Rev. C 11
TONO-PEN AVIA Tonometer Tones
The TONO-PEN AVIA tonometer generates two different tones.
A “BEEP” will sound when:
Power Up Mode fails•
Verication Mode fails•
Applanation Mode starts•
IOP testing is completed•
IOP values are out of range (<5 or >55)•
At various points during the verication test.•
A “CHIRP” will sound when:
A valid IOP measurement has been taken during•
applanation.

12 68E3892 Rev. C
Battery Pack Installation and Replacement
The TONO-PEN AVIA tonometer is supplied with a TONO-PEN AVIA
POWERCEL battery pack that needs to be installed prior to use. The
TONO-PEN AVIA POWERCEL battery pack is the only replacement
battery that can be used with this device.
Insert the TONO-PEN AVIA POWERCEL battery pack into the base1.
of TONO-PEN AVIA tonometer until fully seated. The battery pack is
“keyed” for correct installation.
Press the Activation Button.2.
Check that the battery symbol in the LCD has all segments3.
displayed.
Check that the Self-Test is initiated.4.
Dispose of used battery packs in accordance with local regulations.5.
Figure 2. TONO-PEN AVIA POWERCEL
Battery Pack Installation and Replacement

68E3892 Rev. C 13
Liquid Crystal Display (User Interface)
ILLUSTRATION NAME RESULT
POWER UP MODE - USER INTERFACE SEQUENCE OF EVENTS
1 User Interface
LCD/Battery Test
LED Off
Passed Battery Life Test/
Passed LCD Test
2 (SEE APPLANATION MODE)
POWER UP MODE - USER INTERFACE ERROR CODES
User Interface
Error Code
LED Off
Battery Level Critical (when
low, symbol will ash)
User Interface
Error Code
LED Off
Failed Self Test
APPLANATION MODE - USER INTERFACE SEQUENCE OF EVENTS
1
User Interface
Ready to
Measure
LED On, 1 Beep
Ready to Begin IOP Testing
(15 seconds for testing
before Time Out)
2 User Interface
Testing Display
LED On
During Test, screen shows
number of applanations
achieved (in this case 4
of 10)
Each applanation taken
equals 1 Chirp
3 User Interface
Test Complete
LED Off, 1 Beep
Test Complete
Patient has an IOP of 16
with a statistical condence
indicator of 95.

14 68E3892 Rev. C
Liquid Crystal Display (continued)
APPLANATION MODE - USER INTERFACE ERROR CODES
User Interface
Error Code
LED Off
Error - IOP value Under
Range (<5mm Hg)
User Interface
Error Code
LED Off
Error- IOP Value Over
Range (>55mm Hg)
User Interface
Error Code
LED Off
Timeout - not enough IOP
values collected
VERIFICATION MODE - SEQUENCE OF EVENTS
User Interface
Begin Verication
Mode
Hold TONO-PEN AVIA
tonometer with transducer
down towards oor
(LED Off)
User Interface
Invert Pen
Invert TONO-PEN AVIA
tonometer (LED Off)
User Interface
Successful
Verication
Successful TONO-PEN
AVIA tonometer verication
(LED Off)
VERIFICATION MODE - USER INTERFACE ERROR CODE
User Interface
Error Code
Unsuccessful TONO-PEN
AVIA tonometer verication
(LED Off)

68E3892 Rev. C 15
TONO-PEN AVIA Tonometer Preparation
Allow the instrument to thermally stabilize to room1.
temperature for approximately 30 minutes prior to use.
Remove the storage OCU-FILM tip cover from the tip.2.
Visually inspect the tonometer’s sensor for cracks, chips3.
or other irregularities. Do not use if these conditions
are present.
Place a new OCU-FILM tip cover over the tip until the ridge4.
is seated, taking care not to apply the tip cover too tightly
or too loosely.
Figure 3. TONO-PEN AVIA Tonometer Preparation

16 68E3892 Rev. C
Verication Mode
A verication Test may be performed to ensure that the sensor
and electronics are performing as expected. A verication test
may also be initiated if suspect readings are observed. (See
earlier section “TONO-PEN AVIA TONOMETER Verication” for
details.)
If the verication test resulted with the LCD displaying “Fail”,
repeat the verication test, or reference the troubleshooting
section for potential causes for test failure.
Note: The TONO-PEN AVIA tonometer will remain in the
Verication mode until it passes verication.

68E3892 Rev. C 17
Performing IOP Measurements
WARNING: OCU-FILM tip covers contain natural
rubber Latex which may cause allergic reactions.
Question patients about allergies to Latex before
measuring them with the TONO-PEN AVIA tonometer.
1. Instill a drop of topical anesthetic into the eye to
be examined.
2. Position the patient, seated or supine, in front of
a xation target.
Note: The TONO-PEN AVIA tonometer will
function in any orientation.
3. Instruct the patient to look straight ahead at the
xation target (i.e. ear, nose, distant object) to
minimize eye movement, with eyes fully open.
4. Hold the TONO-PEN AVIA tonometer as you would
a pencil and position yourself to allow viewing of the
sensor and the patient’s cornea where contact will
be made. For normal corneas, central corneal contact
is recommended.
5. The corneal surface needs only to be momentarily
contacted. Indentation or additional pressure is not
required and may lead to injury to the eye.
6. Brace the heel of your hand on the patient’s cheek
for stability while holding The TONO-PEN AVIA
tonometer perpendicular to and within approximately
1.3 cm (1/2”) of the patient’s cornea.
Note: In the unlikely event an Electrostatic Discharge
(ESD) occurs, the TONO-PEN AVIA tonometer
may display inaccurate data. Simply re-press the
Activation button and start the measurement again.

18 68E3892 Rev. C
Applanation
Press and release the activation button once to initiate the1.
applanation mode.
A brief display of “882. 888” will ash on the LCD, a double row
of dashes “===” will be displayed, the green LED will turn on,
and a “beep” tone will sound, indicating the TONO-PEN AVIA
tonometer is ready to measure intraocular pressure.
Tap the sensor very lightly and briey on the corneal surface, the 3.
device will chirp and the DATA eld on the LCD will increment for
each valid IOP reading obtained.
When another beep tone is heard, indicating 10 applanations4.
have been read, the green LED will turn OFF, and the averaged
IOP measurement will appear on the LCD above “mmHg”. The
statistical condence indicator will appear on the LCD above
DATA.
Notes:
• If at least 6 applanations were read, the IOP will be displayed
after a 4 second delay, along with the statistical condence
indicator.
• After pressing the Activation button, do not shake the
TONO-PEN AVIA tonometer as it may register a reading.
If this occurs simply re-press the Activation button and start
the measurement again.
If 15 seconds elapse prior to applanation being initiated, the
TONO-PEN AVIA tonometer will initiate the Sleep Mode, indicated
initially by the display of a single row of dashes “---”, followed by a
blank display. The applanation mode may be initiated by pressing
the activation button.
If any error codes appear on the LCD after the nal beep, the
applanation procedure must be repeated.

68E3892 Rev. C 19
Interpreting the IOP Measurement
During the measurement, the LCD shows the cumulative number
of applanations detected. Once 10 applanations are achieved, the
LCD will display the IOP in millimeters of mercury (mm Hg), along
with a statistical condence indicator.
A statistical condence indicator of 95 means that the standard
deviation of the valid measurements is 5% or less of the number
shown. The higher the statistical condence indicator, the more
reliable the measurement.
If the statistical condence indicator is 80 or 80-, a repeat
measurement is recommended.
Figure 4. Closeup of TONO-PEN AVIA Tonometer LCD
showing an IOP measurement of 16 and statistical
condence indicator of 95

20 68E3892 Rev. C
Maintenance and Storage
Cleaning Instructions
The TONO-PEN AVIA tonometer
may have difculty taking
measurements or display “Fail”
after a calibration when its tip
is dirty and requires cleaning.
When the tip of the tonometer
has dirt and contaminants in the
airspace between the sensor and
the housing, cleaning of the tip
is necessary. When the airspace
contains contaminants, the sensor
cannot move freely and the
tonometer may have erratic readings and then show a “Fail” calibration.
To clean the tonometer, perform the following steps:
Remove1. OCU-FILM tip cover from the tonometer, if one is installed.
Using canned air, place the sensor end of the tonometer against the2.
outlet of the canned air as shown in Figure 8.
Blow the canned air into the tip of the tonometer for approximately 33.
seconds.
Note: It is necessary to blow canned air directly into the tip, so that the
contaminants are pushed out of the airspace between the sensor and the
housing.
After cleaning the tip of the tonometer with compressed air, the tip will4.
be cold. Allow the tip of the tonometer to warm to room temperature.
Perform the tonometer calibration as indicated in the5. TONO-PEN
AVIA Verication section of this manual.
Note: If the tonometer does not “Pass” the Verication Procedure, then repeat
the above cleaning instructions. Do not clean more than 3 times in a row. If the
tonometer still will not calibrate, contact Reichert.
Note: Always store the TONO-PEN AVIA tonometer with an OCU-FILM tip cover
installed to protect the tonometer tip from dirt and contaminants.
Note: Never use the TONO-PEN AVIA tonometer without an OCU-FILM tip cover
installed.