Reichert TONO-PEN XL User manual

User’s Guide
TONO-PEN®XL Tonometer

268E3441 Rev.F
©2012 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.
ISO 9001/13485 Certied – Reichert products are designed and manufactured under
quality processes meeting ISO 9001/13485 requirements.
Caution: Federal law restricts this device to sale by or on the
order of a licensed physician. Rx Only.
The following are registered trademarks of
Reichert, Inc.
Reichert®
Tono-Pen XL®
Tono-Pen AVIA POWERCEL®
Ocu-Film®

3
68E3441 Rev.F
Table of Contents
Introduction 4
Warnings and Cautions 6
Setup 8
Calibration 11
Taking a Measurement 13
Interpreting the LCD 16
Maintenance & Storage 17
Specications     20
Symbols     21
Troubleshooting    22
GuidanceandManufacturer’sDeclaration 23
Accessories     26
Warranty     27

468E3441 Rev.F
Overview
The Reichert Tono-Pen XL is a precision electronic tonometer which
measures intraocular pressure (IOP). The body of the instrument is
specially designed to t comfortably in the user’s hand, facilitating fast
and accurate measurements. The stainless steel probe on the Tono-
Pen XL contains a solid state strain gauge which converts intraocular
pressure (IOP) to an electrical signal. The probe tip must be covered
by a protective membrane. Reichert Ocu-Film®Tip Covers are
recommended.
Utilizing a sophisticated “single chip” microprocessor and electronics
housed in the body of the instrument, the waveform produced by each
touch to the anesthetized corneal surface is analyzed and stored for a
statistical comparison process. Each single valid IOP reading is digitally
displayed on the liquid crystal display (LCD). When four valid readings
are obtained, the mean IOP and the standard deviation for those
readings (an indication of reliability) are shown on the LCD.
Intended Use
The Tono-Pen XL tonometer is a prescription only device intended for
measuring intraocular pressure (IOP) during routine eye examinations
or when increased intraocular pressure is suspected by properly trained
eyecare professionals such as ophthalmologists, optometrists, opticians,
and eye care technicians.
Indications for Use
The indications for use include measuring intraocular pressure
(IOP) for suspected glaucoma, or when increased intraocular
pressure is suspected.
Contraindications
None:
Components
The Tono-Pen XL unit (see Figure 1) is provided in a storage case,
complete with:
OCU-CEL™ XL Batteries (P/N 230570)
•
Stylus Blade for battery replacement (P/N 23050140)•
Instruction Manual (P/N 68E3441)•
Instructional DVD (not shown in Figure 1) (P/N 980079)•
Introduction

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68E3441 Rev.F
Figure 1 Tono-Pen XL Components (in Storage Case)
Introduction (Continued)
Tono-Pen XL
Tonometer
Stylus Blade
OCU-CEL XL
Batteries
Instruction Manual

668E3441 Rev.F
WARNING: An instruction that draws attention to risk of injury or
death.
WARNING: Any repair or service to this instrument must be performed
by experienced personnel or dealers who are trained by Reichert so that
correct operation of this instrument is maintained.
WARNING: Modications to this instrument is not allowed. Any
modication to this unit must be authorized by Reichert so that correct
operation is maintained.
WARNING: If this instrument is modied, appropriate inspection
and testing must be conducted to ensure continued safe use of this
instrument.
WARNING: Do not use the TONO-PEN XL tonometer on a patient without
an OCU-FILM®tip cover or inaccurate readings may be obtained.
WARNING: Do not use the TONO-PEN XL 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 XL 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 XL tonometer.
CAUTION: An instruction that draws attention to the risk of damage
to the product.
CAUTION: Do not use the TONO-PEN XL tonometer without an
OCU-FILM tip cover to prevent damage to the sensor.
Warnings and Cautions

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68E3441 Rev.F
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.
CAUTION: Do not immerse the TONO-PEN XL tonometer in uids
or damage to the electronics may occur.
CAUTION:
Do not attempt to sterilize the TONO-PEN XL tonometer
or damage to the electronics may occur.
CAUTION: Do not attempt to modify the TONO-PEN XL tonometer or
the TONO-PEN XL POWERCEL battery pack or damage to the device may
occur.
CAUTION: Do not store the TONO-PEN XL tonometer without an
OCU-FILM tip cover or debris may enter the sensor and transducer
assembly and cause malfunctions.
CAUTION: The TONO-PEN XL tonometer should not be used adjacent to
or stacked with other equipment. If adjacent or stacked use is necessary,
the TONO-PEN XL 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 XL POWERCEL BATTERY PACK
WARNING: Do not carry the TONO-PEN XL POWERCEL battery pack
in a pocket, or close to your person, as a burn injury may result.
CAUTION: Do not expose to high temperatures (>70°C / >158°F).
CAUTION: Do not attempt to recharge.
CAUTION: Do not disassemble.
Warnings and Cautions (Continued)

868E3441 Rev.F
Set Up Instructions
To set up the Tono-Pen XL for operation, follow the instructions listed
below:
Remove all protective packaging materials.1.
Carefully remove the tonometer and accessories from the case.2.
Check for missing items.3.
Visually check the instrument and accessories for damage.4.
Remove the Ocu-Film Tip Cover shipped with the Tono-Pen.5.
Notify Reichert Customer Service immediately if any components6.
are missing or damaged.
Install the batteries in the battery compartment (see page 9).7.
Perform the Calibration Procedure (see page 11).8.
Slide a new Ocu-Film Tip Cover over the Tono-Pen XL unit’s 9.
stainless steel probe tip until the Ocu-Film ridge is seated in the
groove (see Figure 2). The Ocu-Film Tip Cover should t over the
probe tip (see Figure 3), without being too tight. Proper t makes
contact with the probe tip, but still has pleats along the side of the
transducer head assembly.
Setup
Groove
Probe Tip Operator’s Button LCD
Battery Compartment
Figure 2 Tono-Pen XL Top and Side Views

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68E3441 Rev.F
Battery Installation
The Tono-Pen XL is supplied with four OCU-CEL XL 3.0 volt lithium
manganese dioxide batteries that need to be installed in the Tono-Pen
XL. It is recommended that Reichert OCU-CEL XL Batteries be used
when the batteries need replacement.
Note: The Tono-Pen XL unit will not function properly with mercury
batteries.
Battery Installation
Locate the battery compartment (see Figure 4). Open the battery1.
compartment by gently inserting the stylus blade (see Figure 4) in
the end slot. After insertion, slowly push the stylus forward and pry
the cover up to remove.
Using the other end of the stylus, insert the tip into the holes on the2.
underside of the body mold. Insert the tip perpendicular into the
battery removal holes on the bottom of the base housing to push
the batteries out (see Figure 4).
Insert two batteries as shown in Figure 4 (also diagrammed on the3.
oor of the battery compartment).
Replace the battery cover.4.
CAUTION: CheCk TO be sUre ThAT The bATTerIes Are
INsTAlled COrreCTly. INCOrreCT INsTAllATION COUld
CAUse severe dAmAge TO The eleCTrONICs ANd vOId The
WArrANTy.
Setup (Continued)
Figure 3 Ocu-Film Tip Cover Placement
OCU-FILM Tip Cover -
CORRECT
OCU-FILM Tip Cover -
Too Loose
OCU-FILM Tip Cover -
Too Tight

10 68E3441 Rev.F
Setup (Continued)
Figure 4 Replacing Batteries
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+-
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