Reichert Model 30 User manual

Model 30™
Pneumatonometer
User’s Guide

©2017 AMETEK, Inc.
Reichert and Reichert Technologies are registered trademarks of Reichert, Inc.
Model 30 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. Specifications subject to change without notice.
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 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.

16030-101 Rev. J 3
Contents
Warnings and Cautions ................................................................................... 4
Symbol Information.......................................................................................... 6
Introduction...................................................................................................... 7
Indications for Use..................................................................................... 7
Contraindications....................................................................................... 7
Instrument Setup ............................................................................................... 8
Unpacking Instructions .............................................................................. 8
Parts Identication ..................................................................................... 9
Models and Options............................................................................ 10
Accessories......................................................................................... 10
Icon Denition.......................................................................................... 11
Default Settings ....................................................................................... 13
General Setup ......................................................................................... 13
Printout Setup.......................................................................................... 14
Service Screen ........................................................................................ 14
Installation ............................................................................................... 15
Pneumatonometer Installation................................................................. 15
Application of Input Power....................................................................... 17
Disconnection of Input Power.................................................................. 18
Quick Verication Check.......................................................................... 19
Operating Principle .................................................................................. 20
Instructions for Use ..........................................................................................21
Patient Preparation.................................................................................. 21
Measurement Protocol ............................................................................ 22
Measurements......................................................................................... 23
Manual Tonometry .............................................................................. 23
Pulse Tonometry................................................................................. 24
Tonography......................................................................................... 25
Seated IOP .................................................................................... 26
Supine IOP .................................................................................... 26
Cleaning & Maintenance ................................................................................. 28
Tip and Membrane Assembly .................................................................. 28
Cleaning the Tip and Membrane Assembly ........................................ 28
Disinfection of the Tip and Membrane Assembly................................ 28
Inspection of the Tip and Membrane Assembly.................................. 28
Fuses....................................................................................................... 29
Calibration Verier Cornea Replacement ................................................ 29
External Cleaning .................................................................................... 29
Printer Paper ........................................................................................... 30
Filter Replacement .................................................................................. 30
Compressor Filter Replacement......................................................... 30
Inline Filter Replacement.................................................................... 30
Troubleshooting................................................................................................31
Specications .................................................................................................. 32
Classications ................................................................................................. 33
Guidance & Manufacturer’s Declarations...................................................... 34
Warranty ........................................................................................................ 39

16030-101 Rev. J
4
Reichert Technologies 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 DE-
VICE BE PURCHASED ONLY BY A PHYSICIAN OR A PERSON ACTING ON BEHALF OF A PHYSICIAN.
WARNING: THIS INSTRUMENT SHOULD BE USED IN STRICT ACCORDANCE WITH THE INSTRUC-
TIONS OUTLINED IN THIS USER’S GUIDE. THE SAFETY OF THE OPERATOR AND THE PERFOR-
MANCE OF THE INSTRUMENT CANNOT BE GUARANTEED IF USED IN A MANNER NOT SPECIFIED BY
REICHERT TECHNOLOGIES.
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 SO THAT CORRECT
OPERATION OF THIS INSTRUMENT IS MAINTAINED OR SERIOUS INJURY TO THE OPERATOR OR
PATIENT MAY OCCUR.
WARNING: MODIFICATIONS TO THIS INSTRUMENT IS NOT ALLOWED. ANY MODIFICATION TO THIS
UNIT MUST BE AUTHORIZED BY REICHERT SO THAT CORRECT OPERATION IS MAINTAINED 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: TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO
A SUPPLY MAINS WITH PROTECTIVE EARTH OR DAMAGE TO THE INSTRUMENT AND/OR INJURY TO
THE OPERATOR OR PATIENT MAY OCCUR.
WARNING: ENSURE THAT THE VOLTAGE APPLIED TO THE UNIT IS THE SAME AS THE VOLTAGE
THAT IS INDICATED ON THE DATA PLATE OR DAMAGE TO THE INSTRUMENT AND/OR INJURY TO
THE OPERATOR OR PATIENT MAY OCCUR.
WARNING: THIS INSTRUMENT MUST BE PLUGGED INTO AN OUTLET WITH AN EARTH GROUND. DO
NOT REMOVE OR DEFEAT THE EARTH GROUND CONNECTION ON POWER INPUT CONNECTOR
OR THE UNIT’S POWER CORD OF THIS INSTRUMENT OR DAMAGE TO IT AND/OR INJURY TO THE
OPERATOR OR PATIENT MAY OCCUR.
WARNING: THE EQUIPMENT OR SYSTEM SHOULD NOT BE USED ADJACENT TO OR STACKED WITH
OTHER EQUIPMENT AND THAT IF ADJACENT OR STACKED USE IS NECESSARY, THE EQUIPMENT
OR SYSTEM SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN
WHICH IT WILL BE USED.
WARNING: THIS INSTRUMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE AN-
ESTHETIC MIXTURES, SUCH AS OXYGEN OR NITROUS OXIDE.
WARNING: DO NOT USE ANY OTHER PROBE WITH THIS INSTRUMENT THAN THOSE SUPPLIED BY
REICHERT EXPRESSLY FOR USE WITH THIS INSTRUMENT. OTHER PROBES MAY CAUSE DAMAGE
OR INJURY TO THE EYE.
WARNING: DO NOT USE THIS INSTRUMENT IF THE MEASUREMENT TIP IS CRACKED, CHIPPED OR
SHOWS ANY IRREGULARITY OF THE SURFACE, TO PREVENT PATIENT INJURY AND OR INACCU-
RATE READINGS.
WARNING: IN ORDER TO PREVENT PATIENT-TO-PATIENT TRANSFER OF INFECTION, AFTER EACH
USE DISINFECT THE MEASUREMENT TIP FOLLOWING ACCEPTED LOCAL CLINICAL PROCEDURES
REGARDING THE USE OF DISINFECTANTS. ANY CLINICALLY APPROVED CHEMICAL DISINFECTANT
CAN BE USED.
Warnings & Cautions

16030-101 Rev. J 5
WARNING: THE USE OF ACCESSORIES OR CABLES OTHER THAN THOSE SPECIFIED, WITH THE
EXCEPTION OF THOSE SOLD BY THE MANUFACTURER AS REPLACEMENT PARTS FOR INTER-
NAL 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: THE INTERNAL CIRCUITRY OF THE INSTRUMENT CONTAINS ELECTROSTATIC DIS-
CHARGE SENSITIVE DEVICES (ESDS) THAT MAY BE SENSITIVE TO STATIC CHARGES PRODUCED
BY THE HUMAN BODY. DO NOT REMOVE THE COVERS WITHOUT TAKING PROPER PRECAUTIONS.
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 DISPLAY. SEE MAINTENANCE SECTION FOR DETAILED CLEANING INSTRUC-
TION.
CAUTION: DO NOT AUTOCLAVE OR DISINFECT USING HIGH TEMPERATURES EXCEEDING THE REC-
OMMENDED TEMPERATURES INDICATED IN THE SPECIFICATIONS SECTION OF THIS MANUAL OR
DAMAGE TO THE UNIT MAY OCCUR.
CAUTION: MEDICAL ELECTRONIC EQUIPMENT NEEDS SPECIAL PRECAUTIONS REGARDING EMC
AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC INFORMATION
PROVIDED IN THE ACCOMPANYING DOCUMENTS.
CAUTION: PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL
ELECTRICAL EQUIPMENT.
CAUTION: THIS INSTRUMENT IS NOT TO BE USED NEAR HIGH-FREQUENCY EMITTING SURGICAL
EQUIPMENT.
CAUTION: THIS INSTRUMENT IS NOT INTENDED TO BE CONNECTED TO EQUIPMENT OUTSIDE THE
CONTROL OF REICHERT INC. OR MUST BE TESTED TO AN APPLICABLE IEC OR ISO STANDARDS.
CAUTION: DO NOT INSTALL ANY ADDITIONAL SOFTWARE OTHER THAN WHAT WAS SUPPLIED WITH
THIS INSTRUMENT. INSTALLATION OF ADDITIONAL SOFTWARE MAY CAUSE UNEXPECTED OPERA-
TION RESULTING IN MALFUNCTION OF THIS INSTRUMENT.
Warnings & Cautions (continued)

16030-101 Rev. J
6
Symbol Information
Symbol Information
The following symbols appear on the instrument:
Caution
Type B Applied Part
Alternating Current Power
Protective Earth Connection
ON / OFF
Manufacturer
2017
Date of Manufacture
REF Catalog Number
S/N Serial Number
Waste of Electrical and Electronic Equipment
Compliance to Medical Device Directive 93/42/EEC
Authorized to mark given by Intertek ETL Semko for conformance
with electrical standards
Accompanying Documents must be consulted
Authorized Representative in European Community
Fragile Contents in Shipping Container - handle with care
Keep Dry - Package shall be kept away from rain
This Way Up - Indicates correct upright position of package
Important Instruction - remove Shipping Bracket

16030-101 Rev. J 7
Congratulations on your purchase of the Reichert®Model 30™Pneumatonometer.
The Model 30 Pneumatonometer is a highly accurate instrument used to measure intraocular pressure
(IOP) non-invasively through applanation tonometry and represents a signicant advance in tonometry and
tonography technology over its predecessors. The pneumatonometer system consists of the base unit,
a probe, and the necessary accessories to accurately measure tonometry/tonography in one easy-to-use
unit. This manual describes its operation and details. Most individuals will nd this instrument easy to use
following the software and audible prompts.
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. Properly trained eyecare professionals
such as ophthalmologists, optometrists, opticians and eye care technicians should operate this instrument.
Please retain this guide for future reference and to share with other users. Additional copies can be
obtained from your authorized Reichert Technologies dealer or contact our Customer Service department
directly at:
Tel: [phone]
Fax: [phone]
Email: [email protected]
Please indicate the following when contacting Reichert to ensure that you receive the correct information:
• Model Number
• Serial Number
• Contact Phone Number or Email Address
Indications for use
The Model 30 Classic Pneumatonometer is intended for the measurement of intraocular pressure. The
Model 30 Classic Pneumatonometer is indicated for use as a screening / monitoring tool for glaucoma or
when increased intraocular pressure is suspected.
Contraindications
None.
Introduction

16030-101 Rev. J
8
Instrument Setup
Great care has been taken to deliver this instrument to you safely. The container and packaging was
specially designed to transport this unit. Please retain the packaging if future transportation is required.
Please remove the packaging material from the outer box and then remove the pneumatonometer and its
accessories from the box. Refer to Figures 1-1 through 1-3.
Unpacking Instructions
Please remove the packaging material from the instrument in the following
manner. Refer to Figures 1-1 through 1-3.
The instrument is packaged in a shipping container to protect the
instrument from damage during shipment. Please read the User’s Guide
before operating the unit. The pneumatonometer includes the following
accessories:
1. User’s Guide (not shown)
(P/N 16030-101)
2. Spare Tip and Membrane Assembly
(P/N 230676)
3. Pneumatonometer Probe
(P/N 232349)
4. Power Cord
(P/N WCBL10018 for 16030 & 16032
or P/N WCBL10027 for 16031)
5. Footswitch
(P/N 232345 - only available with P/N 16033 kit)
6. Thermal Paper
(P/N 232348)
7. Calibration Verier
(P/N 232373)
8. Yellow Shipping Bracket (not shown)
(P/N 16030-009)
(attached to the unit when shipped).
Figure 1-1, Unpacking Unit
Figure 1-2, Unit with Foam
2
Figure 1-3, Accessories
6
7
34
5

16030-101 Rev. J 9
Instrument Setup (continued)
Parts Identication
The Model 30 Pneumatonometer is housed in a single compact metal case that fits easily on most coun-
ters or an appropriate stand.
The front panel of the Model 30 Pneumatonometer includes: (Refer to the Figure 1-4.)
1. ON/ OFF switch
2. Built-in chart
3. LCD readout
4. Connector for the pneumatic probe.
The rear panel of the Model 30 Pneumatonometer (Figure 1-5) includes:
1. Access door for changing filters and removing the yellow shipping bracket.
2. Receptacle for the optional footswitch, which allows the operator to select system functions while using
his/her hands to restrain the patient’s eyelid and position the probe.
3. Three-prong plug for the AC power cord that connects the Model 30 Pneumatonometer to an electrical
outlet with an integral fuse holder.
4. USB connection for factory data communication.
Note: The USB connection is only for use by the manufacturer, for service repairs. This port cannot be
used to transfer data or connect to an external printer.
Figure 1-5, Pneumatonometer Parts (Rear)
1
2
3
4
Figure 1-4, Pneumatonometer Parts (Front)
1
23
4

16030-101 Rev. J
10
Instrument Setup (continued)
Parts Identication
Models and Options
The specifications for the different models of the pneumatonometer are found in the General Specifi-
cations section of this manual.
The pneumatonometer is a tonometer that provides the following tests: manual tonometry, pulse
tonometry or tonography.
In the manual mode, the pneumatonometer provides a single pressure value and ends the test when
the probe is removed from the surface of the patient’s eye. The pulse mode provides pressure
output with pulse fluctuations and ends the test after it has read ten ocular pulses or the probe is
removed from the eye surface. The tonography test records changes in IOP when a weighted probe
is held on the cornea for a specified time. The tonography test enables the operator to conduct a
two-minute or four-minute test for each eye.
The Model 30 Pneumatonometer handpiece and probe assembly (Figure 1-6) includes:
1. Tip and membrane assembly (Applied Part)
2. Auto sensor assembly and probe handle
3. Double lumen tubing
4. Quick-flow connector
Accessories (Optional)
Part Number Description
16033 Tonography Kit (includes Foot Pedal & 10 Gram Weight)
230676 Tip and Membrane Assembly, 1 pk
230677 Tip and Membrane Assembly, 3 pk
230678 Tip and Membrane Assembly, 10 pk
232346 Filter Kit
232348 Printer Paper
232373 Calibration Verifier
(To order any of these accessories, contact your local authorized Reichert dealer.)
Figure 1-6, Pneumatonometer Probe
2
1
3
4