Ametek Tono-Pen XL User manual

Tono-Pen®XL
Tonometer
User’s Guide

©2017 AMETEK, Inc.
Reichert, Reichert Technologies, Tono-Pen and Ocu-Film are registered trademarks of
Reichert, Inc.
OCU-CEL is a trademark of Reichert, Inc.
AMETEK is a registered trademark of AMETEK, Inc.
All other trademarks are property of their respective owners.
The information contained in this document was accurate at time of publication. Speci-
fications subject to change without notice. Reichert, Inc. reserves the right to make
changes in the product described in this manual without notice and without incorporat-
ing those changes in any products already sold.
ISO 9001/13485 Certified – Reichert products are designed and manufactured under
quality processes meeting ISO 9001/13485 requirements.
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, or
otherwise, without the prior written permission of Reichert, Inc.
Caution: Federal law restricts this device to sale by or on the order of
a licensed physician. Rx only.
The Tono-Pen XL Tonometer Help Line
Should you need immediate help with a technical question or guid-
ance through the appropriate procedure, just call the Help Line at
888-849-8955
Note: When contacting our Technical Service Group at Reichert,
please have the appropriate product number, product serial
number, date of purchase, and nature of inquiry available.
Product Number: _______________________________
Serial Number: _________________________________
Date of Purchase: ______________________________

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Warnings & Cautions........................................................4
Symbols............................................................................8
Introduction.......................................................................9
Indications for Use.......................................................9
Contraindications.........................................................9
Device Description.....................................................10
Features ....................................................................10
Parts Identication.....................................................11
Available Accessories ................................................11
Setup ..............................................................................12
Battery Installation.....................................................12
Tono-Pen XL Tonometer Preparation ........................13
Calibration Procedure................................................14
Instructions for Use.........................................................16
Performing IOP Measurements .................................16
Interpreting the LCD Screen......................................19
Cleaning & Maintenance ................................................20
Cleaning Instructions.................................................20
Tono-Pen XL Body................................................21
Battery Replacement.................................................21
Storage......................................................................22
Disposal.....................................................................22
Troubleshooting..............................................................23
Specications .................................................................24
Classications.................................................................25
Guidance and Manufacturer’s Declaration .....................26
Warranty .........................................................................30
Table of Contents

468E3441 Rev. J
Warnings & Cautions
Reichert Technologies (Reichert) is not responsible for the safety and
reliability of this instrument when:
• Assembly, disassembly, repair, or modication 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.
WARNING: DO NOT REPAIR OR SERVICE THIS INSTRUMENT
WITHOUT AUTHORIZATION FROM THE MANUFACTURER. ANY
REPAIR OR SERVICE TO THIS INSTRUMENT MUST BE PERFORMED
BY EXPERIENCED PERSONNEL OR DEALERS WHO ARE TRAINED
BY REICHERT OR SERIOUS INJURY TO THE OPERATOR OR PATIENT
MAY OCCUR.
WARNING: THIS INSTRUMENT SHOULD BE USED IN STRICT
ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN THIS USER’S
GUIDE. THE SAFETY OF THE OPERATOR AND THE PERFORMANCE
OF THE INSTRUMENT CANNOT BE GUARANTEED IF USED IN A
MANNER NOT SPECIFIED BY REICHERT TECHNOLOGIES.
WARNING: MODIFICATIONS TO THIS INSTRUMENT ARE NOT ALLOWED.
ANY MODIFICATION TO THIS UNIT MUST BE AUTHORIZED BY
REICHERT OR SERIOUS INJURY TO THE OPERATOR OR PATIENT MAY
OCCUR.
WARNING: IF THIS INSTRUMENT IS MODIFIED, 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 AN OCU-FILM + TIP COVER ON MORE THAN
ONE PATIENT TO HELP PREVENT CROSS CONTAMINATION.
WARNING: IT IS IMPERATIVE THAT A FRESH OCU-FILM + TIP COVER
BE USED FOR EACH PATIENT FOR THE PROTECTION OF THE EYE
AND THE TRANSDUCER ASSEMBLY. THE TRANSFER OF INFECTION
IS THUS PREVENTED. REPLACE OCU-FILM + TIP COVERS AFTER
EXAMINATION OF EACH PATIENT.

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68E3441 Rev. J
Warnings & Cautions (continued)
WARNING: DO NOT USE THE TONO-PEN XL TONOMETER IF THE
TRANSDUCER ASSEMBLY 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
TAPPED, INDENTATION OR ADDITIONAL PRESSURE AFTER THE
AUDIO “CHIRP” TONE IS HEARD IS NOT REQUIRED AND MAY LEAD TO
DAMAGE TO THE EYE. IF MEASUREMENT PROCESS CAUSES PATIENT
DISCOMFORT, DEVICE DOES NOT SHOW A MEASUREMENT, OR IF
DEVICE REQUIRES MULTIPLE ATTEMPTS TO OBTAIN A MEASUREMENT,
STOP THE EXAMINATION AND REFER TO THE TROUBLESHOOTING
SECTION OF THIS MANUAL.
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.
WARNING: DO NOT CARRY THE TONO-PEN XL OCU-CEL BATTERIES
IN A POCKET, OR CLOSE TO YOUR PERSON, AS A BURN INJURY MAY
RESULT.
WARNING: THE BATTERY SHOULD ONLY BE REPLACED WITH THE
BATTERY SPECIFIED IN THIS MANUAL. USE OF ANOTHER BATTERY
MAY CAUSE FIRE OR AN EXPLOSION.
WARNING: DO NOT PLACE A SHORTING DEVICE BETWEEN THE
BATTERY TERMINALS, OR ALLOW THE BATTERY TO BECOME WET.
MISUSE OR IMPROPER DISPOSAL OF THIS BATTERY MAY CAUSE IT
TO BECOME VERY HOT, IGNITE OR EXPLODE. DAMAGE TO THIS UNIT
AND/OR SERIOUS PERSONAL INJURY MAY RESULT.
WARNING: DO NOT RECHARGE THE BATTERY. THE BATTERY IS
NOT DESIGNED TO BE CHARGED BY ANY ELECTRICAL SOURCE.
CHARGING COULD GENERATE GAS AND INTERNAL SHORT-
CIRCUITING, LEADING TO DISTORTION, LEAKAGE, OVERHEATING,
EXPLOSION OR FIRE.
WARNING: DO NOT EXPOSE THE BATTERY TO TEMPERATURES
ABOVE 140ºF, DISASSEMBLE THE BATTERIES, OR DAMAGE TO THIS
UNIT AND/OR SERIOUS PERSONAL INJURY MAY RESULT.

668E3441 Rev. J
WARNING: NEVER ALLOW LIQUID LEAKING FROM THE BATTERY
TO GET IN YOUR EYES OR MOUTH AS THIS LIQUID COULD CAUSE
SERIOUS PERSONAL INJURY. IF IT COMES IN CONTACT WITH YOUR
EYES OR MOUTH, FLUSH THEM IMMEDIATELY WITH PLENTY OF
WATER AND CONSULT A PHYSICIAN.
WARNING: ALWAYS KEEP BATTERIES OUT OF THE REACH OF
INFANTS AND YOUNG CHILDREN TO PREVENT THEM FROM BEING
SWALLOWED. IF SWALLOWED, CONSULT A PHYSICIAN IMMEDIATELY.
WARNING: THE USE OF ACCESSORIES OR CABLES OTHER THAN
THOSE SPECIFIED, WITH THE EXCEPTION OF THOSE SOLD BY
THE MANUFACTURER AS REPLACEMENT PARTS FOR INTERNAL
COMPONENTS, MAY RESULT IN INCREASED EMISSIONS OR
DECREASED IMMUNITY OF THE EQUIPMENT OR SYSTEM.
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 TRANSDUCER
ASSEMBLY.
CAUTION: DO NOT TOUCH THE TRANSDUCER ASSEMBLY
WITHOUT AN OCU-FILM + TIP COVER APPLIED OR DAMAGE TO THE
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
FLUIDS OR DAMAGE TO THE ELECTRONICS MAY OCCUR.
CAUTION: DO NOT USE SOLVENTS OR STRONG CLEANING
SOLUTIONS ON ANY PART OF THIS INSTRUMENT AS DAMAGE TO
THE UNIT MAY OCCUR. SEE MAINTENANCE SECTION FOR DETAILED
CLEANING INSTRUCTION.
CAUTION: USE OF AMMONIA BASED CLEANERS ON THE LIQUID
CRYSTAL DISPLAY (LCD) MAY CAUSE DAMAGE TO THE DISPLAY. SEE
MAINTENANCE SECTION FOR DETAILED CLEANING INSTRUCTION.
CAUTION: DO NOT ATTEMPT TO STERILIZE THE TONO-PEN XL
TONOMETER OR DAMAGE TO THE ELECTRONICS MAY OCCUR.
Warnings & Cautions (continued)

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68E3441 Rev. J
Warnings & Cautions (continued)
CAUTION: DO NOT AUTOCLAVE OR DISINFECT USING HIGH
TEMPERATURES EXCEEDING THE RECOMMENDED TEMPERATURES
INDICATED IN THE SPECIFICATIONS SECTION OF THIS MANUAL OR
DAMAGE TO THE UNIT MAY OCCUR.
CAUTION: DO NOT ATTEMPT TO MODIFY THE TONO-PEN XL
TONOMETER OR THE TONO-PEN
XL OCU-CEL BATTERIES 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 TRANSDUCER
ASSEMBLY AND CAUSE MALFUNCTIONS.
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.
CAUTION: PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT
CAN EFFECT MEDICAL ELECTRICAL EQUIPMENT.
CAUTION: THIS INSTRUMENT IS NOT TO BE USED NEAR HIGH-
FREQUENCY EMITTING SURGICAL EQUIPMENT.
CAUTION: OCU-FILM + TIP COVERS SHOULD BE STORED BETWEEN
35° AND 80° FAHRENHEIT (2°-27° CELSIUS).
CAUTION: EACH BOX OF HIGH QUALITY OCU-FILM + TIP COVERS
HAS A “USE BEFORE” DATE STAMPED ON THE BOX. WE SUGGEST
USE OF OUR OCU-FILM + BEFORE THIS DATE TO GUARD AGAINST
THE POSSIBILITY OF SHELF WEAR. THE LATEX MATERIAL USED IN
THE OCU-FILM + TIP COVERS CAN DEGRADE. A DEGRADED FILM
MAY RESULT IN LEAKAGE OF WETTING SOLUTION AND INSTRUMENT
DAMAGE. EXAMINE EACH OCU-FILM + TIP COVER FOR YELLOWING,
CRACKS, OR A STICKY TEXTURE PRIOR TO USE.

868E3441 Rev. J
Symbols
Caution
REF Catalog Number
SN Serial Number
2017
Date of Manufacture
Manufacturer
Waste of Electrical and Electronic Equipment
Compliance to Medical Device Directive 93/42/EEC
Consult Instructions for Use
Authorized Representative in European Community
Fragile Contents in Shipping Container - handle with
care
Do not get Shipping Container wet
Type BF Applied Part
SYMBOLS FOR OCU-FILM + TIP COVERS ONLY
Do not reuse. Single Use
Use By
LOT Lot Number
Contains natural rubber latex

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68E3441 Rev. J
Congratulations on your purchase of the Reichert®Tono-Pen®XL
tonometer.
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.
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
XL tonometer will provide you with fast, accurate and reliable measurements
for many years. Properly trained eyecare professionals such as ophthal-
mologists, optometrists, opticians and eye care technicians should operate
this instrument.
Please retain this manual for future reference and to share with other
users. For additional copies of this manual or questions related to the
Tono-Pen XL tonometer, contact your local authorized Reichert®dealer or
contact our Customer Service department directly at:
Tel: [phone]
Toll Free: 888-849-8955
Fax: [phone]
E-mail: [email protected]
Indications for Use
The indications for use include measuring intraocular pressure (IOP)
for suspected glaucoma, or when increased intraocular pressure is
suspected.
Contraindications
None.
Introduction

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Introduction (continued)
Device Description
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.
Features
The Tono-Pen XL tonometer has the following features:
• Easy to use - IOP can be measured reliably by medical professionals.
• Portable - The Tono-Pen XL tonometer weighs just 59.4 g (2.1 oz) and
is battery operated.
• Accurate - The measurements from the Tono-Pen XL tonometer
correlate strongly with Goldmann applanation tonometry and direct
measurements of IOP.
• Versatile - The Tono-Pen XL tonometer may be used easily with the
patient in any position, making the instrument suitable for the office, in
glaucoma clinics, at the hospital bedside, and in remote locations.