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 Certied – 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
Specications 20
Symbols 21
Troubleshooting 22
GuidanceandManufacturer’sDeclaration 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
5
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
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