Ametek Reichert Phoroptor VRx User manual

Phoroptor®VRx
Digital Refraction System
User’s Guide

©2017 AMETEK, Inc.
Reichert, Reichert Technologies, Phoroptor, and ClearChart are registered trademarks of Reichert, Inc.
AMETEK is a registered trademark of AMETEK, Inc.
Bluetooth is a registered trademark of Bluetooth SIG.
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.
Refer to IEC 60601-1 for system level information.
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 practitioner. Rx only.

Table of Contents
Contents
Warnings and Cautions.......................................................................................................................6
Symbol Information..............................................................................................................................8
Introduction..........................................................................................................................................9
Indications for Use.........................................................................................................................9
Contra-Indications .........................................................................................................................9
Unpacking Instructions......................................................................................................................10
Parts Identication ............................................................................................................................12
Setup.................................................................................................................................................14
Connecting the Phoroptor VRx System Components .................................................................14
Leveling the Phoroptor Head.......................................................................................................16
Face Shields................................................................................................................................17
Near Vision Rod and Card...........................................................................................................18
Turn the Unit On and Off .............................................................................................................18
Connect External Devices to the Phoroptor VRx...............................................................................19
Connect External Devices with Reichert Wireless Serial Adapters...................................................20
Connect Acuity Systems to the Phoroptor VRx.................................................................................24
Connecting Multiple Phoroptor VRx Units.........................................................................................25
User Guide Standards.......................................................................................................................27
Controller Keypad..............................................................................................................................28
Icon Description.................................................................................................................................29
Active Data Field .........................................................................................................................29
Auxiliary Lenses or Filters ...........................................................................................................30
Controller Button Descriptions and Effects..................................................................................31
Options/Setup Menu..........................................................................................................................32
Screens Available through the Options/Set-Up Menu.................................................................32
Settings........................................................................................................................................33
Language.....................................................................................................................................33
Refraction Sequence...................................................................................................................33
Aperture Default ..........................................................................................................................33
Cylinder +/- .................................................................................................................................34
Axis 0/180....................................................................................................................................34
Prism Units..................................................................................................................................34
Retinoscopy.................................................................................................................................34
Fog Amount.................................................................................................................................34
BB Fog Amount ...........................................................................................................................34
VA Up Arrow.................................................................................................................................34
NRA/PRA Order...........................................................................................................................34
Near Chart Units..........................................................................................................................34
CC ...............................................................................................................................................35
XCyl Auto.....................................................................................................................................35
XCyl Mode...................................................................................................................................35
XCyl Equal Keypad Button..........................................................................................................35
Date Format.................................................................................................................................36
Time format..................................................................................................................................36
Keypad LED ................................................................................................................................36
Sleep ...........................................................................................................................................36
Output Options ............................................................................................................................36
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16241-101 Rev. D

Table of Contents (continued)
Programs...........................................................................................................................................39
Creating a Program.....................................................................................................................39
Selecting Charts for Program Steps............................................................................................40
Modifying a Step in the Program.................................................................................................41
Deleting a Step from your Program.............................................................................................41
Copying a Program already created............................................................................................41
Exporting a Program....................................................................................................................41
Importing a Program from an outside source (USB drive)...........................................................42
Clearing a Program .....................................................................................................................42
Running a Program .....................................................................................................................43
Charts................................................................................................................................................44
Selecting a Chart.........................................................................................................................44
Chart for Optotypes.....................................................................................................................45
Default Chart ...............................................................................................................................45
Prism Default Charts ...................................................................................................................45
XCyl Default Charts.....................................................................................................................46
Phoria Default Charts..................................................................................................................46
Vergence Default Charts .............................................................................................................46
Binocular Balance (BB) Default Charts .......................................................................................46
Ports..................................................................................................................................................47
Setting-Up a Port for Communication with an External Device...................................................47
Service Menu.....................................................................................................................................48
System Information......................................................................................................................48
Set Date/Time..............................................................................................................................49
Phoroptor Test .............................................................................................................................49
Keyboard Test..............................................................................................................................50
Import Settings and Export Settings............................................................................................51
Factory Settings...........................................................................................................................51
Instructions for Use............................................................................................................................52
Introduction..................................................................................................................................52
Aligning the Phoroptor Head .......................................................................................................52
Data Input..........................................................................................................................................55
Data Table....................................................................................................................................55
Entering Data Manually...............................................................................................................56
Inputting Data Electronically........................................................................................................57
Adjust Values.....................................................................................................................................59
Adjusting a Refraction From Previously Saved, Transferred, or Input Data................................59
Eye Selection...............................................................................................................................59
Sphere.........................................................................................................................................60
Cylinder .......................................................................................................................................61
Sphere and Cylinder - Maintaining Spherical Equivalent ............................................................62
Axis..............................................................................................................................................63
Near Vision Addition ....................................................................................................................64
Cross Cylinder...................................................................................................................................65
Cross Cylinder - Smart/Manual/Split Cyl Test....................................................................................66
Cross Cylinder Test Settings........................................................................................................66
Examination for Astigmatism.......................................................................................................66
Cross Cylinder - Manual Test ............................................................................................................67
416241-101 Rev. D

Table of Contents (continued)
Freely Selectable Axis Adjustment ..............................................................................................68
Cross Cylinder - Smart Test...............................................................................................................69
Axis Adjustment...........................................................................................................................69
Programmed Axis Adjustment .....................................................................................................70
Freely Selectable Axis Adjustment ..............................................................................................70
Programmed Cylinder Power Adjustment....................................................................................71
Freely Selectable Cylinder Power Adjustment.............................................................................71
Cross Cylinder - Split Cyl Test...........................................................................................................72
Axis Adjustment...........................................................................................................................73
Cylinder Power Adjustment .........................................................................................................73
Near Vision Test ................................................................................................................................74
Fused Cross Cylinder Test...........................................................................................................75
NRA/PRA Test .............................................................................................................................77
Amplitude of Accommodation Test ..............................................................................................78
Prism Testing.....................................................................................................................................79
Horizontal Prism - Right Eye .......................................................................................................80
Horizontal Prism - Left Eye..........................................................................................................80
Vertical Prism - Right and Left Eye..............................................................................................80
XY and Polar Coordinates...........................................................................................................80
Split Prism ...................................................................................................................................80
Automated Prism Test - Phorias, Vergences...............................................................................81
Phoria Testing - Distance.............................................................................................................81
Phoria Testing - Near...................................................................................................................83
Vergence Testing or Fusion Range Measurement - Distance .....................................................83
Vergence Testing or Fusion Range Measurement - Near ...........................................................88
Binocular Balance with Prisms..........................................................................................................89
Vertex Distance Calculator................................................................................................................90
Saving VisualAcuity - Distance.........................................................................................................91
Right Eye.....................................................................................................................................91
Left Eye .......................................................................................................................................91
Binocular Vision...........................................................................................................................91
Saving Refraction Data......................................................................................................................92
Comparing Refraction Data...............................................................................................................93
Data Output - EMR............................................................................................................................94
EMR Output Options ...................................................................................................................95
Data Output.................................................................................................................................95
Data Output - Printing........................................................................................................................96
Printer Data Output......................................................................................................................97
Clearing Data.....................................................................................................................................98
Cleaning and Maintenance..............................................................................................................100
Troubleshooting...............................................................................................................................102
Specications ..................................................................................................................................104
Guidance Tables..............................................................................................................................106
Appendix A - Instrument Cables and Bluetooth Kits........................................................................110
Appendix B - Compatibility Chart.....................................................................................................112
Appendix C - Phoroptor VRx, Lensmeter, and Auto Refractor Data................................................113
Appendix D - Phoroptor VRx Data Only..........................................................................................114
Warranty and Limitation of Liability..................................................................................................115
5
16241-101 Rev. D

Warnings and Cautions
Reichert Technologies®(Reichert®) is not responsible for the safety and reliability of this instrument when
unauthorized dealers or persons assemble, disassemble, repair, or modify the instrument, or when
a person does not use the instrument in accordance with this User’s Guide.
WARNING: AN INSTRUCTION THAT DRAWS ATTENTION TO THE RISK OF INJURY OR DEATH.
WARNING: UNITED STATES FEDERAL LAW AND EUROPEAN REGULATIONS REQUIRE THAT ONLY
A LICENSED PRACTITIONER OR A PERSON ACTING ON BEHALF OF A LICENSED PRACTITIONER
PURCHASE THIS DEVICE.
WARNING: THE OPERATOR OF THIS INSTRUMENT SHOULD USE IT IN STRICTACCORDANCE WITH THE
INSTRUCTIONS OUTLINED IN THIS USER’S GUIDE. REICHERT TECHNOLOGIES CANNOT GUARANTEE
THE SAFETY OF THE OPERATORAND THE PERFORMANCE OF THE INSTRUMENT IF THE OPERATOR
USES THE INSTRUMENT IN A MANNER NOT SPECIFIED BY REICHERT TECHNOLOGIES.
WARNING: DO NOT REPAIR OR SERVICE THIS INSTRUMENT WITHOUTAUTHORIZATION FROM THE
MANUFACTURER. EXPERIENCED PERSONNEL OR DEALERS WHOARE TRAINED BY REICHERT MUST
PERFORM ANY REPAIR OR SERVICE TO THIS INSTRUMENT TO PREVENT SERIOUS INJURY TO THE
OPERATOR OR PATIENT.
WARNING: NO PERSON IS ALLOWED TO MODIFY THIS INSTRUMENT. REICHERT MUSTAUTHORIZE
ANY MODIFICATION TO THIS UNIT TO ENSURE CORRECT OPERATION.
WARNING: IF ANY PERSON MODIFIES THIS INSTRUMENT, REICHERT MUST CONDUCT INSPECTION
AND TESTING OF THE INSTRUMENT TO ENSURE ITS CONTINUED SAFE USE.
WARNING: CONNECT THIS EQUIPMENT ONLY TO A SUPPLY MAINS WITH PROTECTIVE EARTH TO
AVOID THE RISK OF ELECTRIC SHOCKAND TO PREVENT DAMAGE TO THE INSTRUMENTAND/OR
INJURY TO THE OPERATOR OR PATIENT.
WARNING: APPLY RATED INPUT VOLTAGE TO THE UNITAS INDICATED ON THE DATA PLATE TO
PREVENT DAMAGE TO THE INSTRUMENTAND/OR INJURY TO THE OPERATOR OR PATIENT.
WARNING: ONLY PLUG THE INSTRUMENT INTO AN OUTLET WITH AN EARTH GROUND. DO NOT
REMOVE OR DEFEAT THE INSTRUMENT’S EARTH GROUND CONNECTION ON THE POWER INPUT
CONNECTOR OR THE UNIT’S POWER CORD, OR YOU COULD CAUSE DAMAGE TO THE INSTRUMENT
AND/OR INJURY TO THE OPERATOR OR PATIENT.
WARNING: DO NOT USE THE EQUIPMENT OR SYSTEM ADJACENT TO OR STACKED WITH OTHER
EQUIPMENT. IF YOU NEED TO USE ADJACENT OR STACKED EQUIPMENT, OBSERVE THE EQUIPMENT
OR SYSTEM TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN WHICH YOU USE IT.
WARNING: RISK OF ELECTRIC SHOCK OR FIRE. THIS DEVICE IS NOT INTENDED TO BE USED WITH
LIQUIDS. DO NOT PLACE OR USE OPEN LIQUID CONTAINERS NEAR THE DEVICE, DUE TO THE RISK OF
SPILLAGE OF LIQUID ONTO THE DEVICE.
WARNING: THIS INSTRUMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE
ANESTHETIC MIXTURES, SUCH AS OXYGEN OR NITROUS OXIDE.
WARNING: THE USE OF ACCESSORIES OR CABLES OTHER THAN THOSE SPECIFIED, WITH THE
EXCEPTION OF THOSE SOLD BY THE MANUFACTURER AS REPLACEMENT PARTS FOR THE INTERNAL
COMPONENTS, MIGHT RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE
EQUIPMENT OR SYSTEM.
Warnings and Cautions
616241-101 Rev. D

Warnings and Cautions(continued)
Warnings and Cautions (continued)
WARNING: PRIOR TO INSTALLING THE PHOROPTOR HEAD ONTO THE STAND ARM, VERIFY THAT THE
ROD ON THE STAND ARM IS SECURE BEFORE ATTEMPTING TO INSTALL THE PHOROPTOR HEAD OR
YOU MIGHT DAMAGE THE UNITAND/OR INJURE THE PATIENT.
WARNING: OTHER ELECTRICAL OR ELECTRONIC EQUIPMENT CAN INTERFERE WITH THE BLUETOOTH
WIRELESS CONNECTION TRANSMITTERS OR RECEIVERS, EVEN IF THAT EQUIPMENTALSO COMPLIES
WITH CISPR EMISSIONS REQUIREMENTS.
CAUTION: AN INSTRUCTION THAT DRAWS ATTENTION TO THE RISK OF DAMAGE TO THE PRODUCT.
CAUTION: THE INTERNAL CIRCUITRY OF THE INSTRUMENT CONTAINS ELECTROSTATIC DISCHARGE
SENSITIVE DEVICES (ESDS) THAT ARE SENSITIVE TO STATIC CHARGES PRODUCED BY THE HUMAN
BODY. DO NOT REMOVE THE COVERS WITHOUT TAKING PROPER ESDS PRECAUTIONS.
CAUTION: DO NOT USE SOLVENTS OR STRONG CLEANING SOLUTIONS ON ANY PART OF THIS
INSTRUMENT TO ENSURE THAT YOU DO NOT DAMAGE THE UNIT. SEE THE MAINTENANCE SECTION
OF THIS GUIDE FOR DETAILED CLEANING INSTRUCTIONS.
CAUTION: DO NOT USEAMMONIA-BASED CLEANERS ON THE LIQUID CRYSTAL DISPLAY (LCD) TO
ENSURE THAT YOU DO NOT DAMAGE THE DISPLAY. SEE THE MAINTENANCE SECTION OF THIS GUIDE
FOR DETAILED CLEANING INSTRUCTIONS.
CAUTION: MEDICAL ELECTRONIC EQUIPMENT REQUIRES SPECIAL PRECAUTIONS REGARDING EMC
AND IT NEEDS TO BE INSTALLED AND PUT INTO SERVICEACCORDING TO THE EMC INFORMATION
PROVIDED IN THEACCOMPANYING DOCUMENTS.
CAUTION: PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CANAFFECT MEDICAL
ELECTRICAL EQUIPMENT.
CAUTION: DO NOT USE THIS INSTRUMENT NEAR HIGH-FREQUENCY EMITTING SURGICAL EQUIPMENT.
CAUTION: THIS INSTRUMENT IS NOT INTENDED TO BE CONNECTED TO EQUIPMENT OUTSIDE THE
CONTROL OF REICHERT TECHNOLOGIES OR IT MUST BE TESTED TO APPLICABLE IEC OR ISO
STANDARDS.
CAUTION: DO NOT INSTALLANY ADDITIONAL SOFTWARE OTHER THAN WHAT IS SUPPLIED WITH THIS
INSTRUMENT. IF YOU INSTALLADDITIONAL SOFTWARE, IT MIGHT CAUSE UNEXPECTED OPERATION,
RESULTING IN INSTRUMENT MALFUNCTION.
CAUTION: YOU MUST PLUG THIS INSTRUMENT INTOAN OUTLET WITHAN EARTH GROUND THAT
IS CONNECTED TO THE RECEPTACLE TO PREVENT DAMAGE TO THE UNIT. DO NOT DISABLE OR
REMOVE THE GROUND PIN.
CAUTION: INGRESS PROTECTION CLASSIFICATION FOR THE PHOROPTOR HEAD IS IP2X, WHILE
THE CONTROLLER, AND CENTRAL UNITARE IP3X. DO NOT SPRAY, SPLASH, OR IMMERSE THESE
INSTRUMENTS IN CLEANING SOLUTIONS.
7
16241-101 Rev. D

Symbol Information
Symbol Information
The following symbols appear on the instrument.
Consult Instructions for Use symbol indicating important operating and maintenance
instructions included in this User’s Guide
Caution symbol indicating important information and maintenance instructions
included in this User’s Guide
Type B Product Classification
Protective Earth
Alternating Current Power
ON / OFF
Date of Manufacture
REF Catalog Number
SN 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
Fragile Contents in Shipping Container - handle with care
Keep Dry - Keep package away from rain
Authorized Representative in European Community
Unplug before opening
2016
816241-101 Rev. D

Introduction
Congratulations on your purchase of the Reichert Technologies (hereafter referred to as Reichert)
Phoroptor®VRx.
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. Only properly trained eye care
professionals, such as ophthalmologists, optometrists, opticians, and eye care technicians should
operate this instrument. All parts of this Medical Electrical system are suitable for use within the patient
environment.
Please retain this guide for future reference and to share with other users. For additional copies of this
manual or questions related to the Phoroptor VRx, contact your local authorized Reichert dealer, or
contact our Customer Service department directly:
Tel: [phone]
Fax: [phone]
Email: [email protected]
Indications for Use
The digital refractor Phoroptor VRx is designed for:
• Subjective measurement of the refractive error of the eye.
• Determination of correction data for refraction anomalies and binocular functions as the basis for
manufacturing eyeglasses and contact lenses.
• Use in refraction rooms in clinics and practices of physicians, optometrists, or opticians.
• Connection to other medical examination equipment or to an ofce Electronic Medical Records
(EMR) system.
• Operation by physicians, optometrists, opticians, or properly trained clinical personnel.
• Installation under the conditions for medical equipment.
• The digital refractor Phoroptor VRx with Prism is additionally designed for:
• Measurement of ocular deviation in patients with latent or manifest strabismus.
Contra-Indications
• There are none associated with the Phoroptor VRx system.
Introduction
9
16241-101 Rev. D

Unpacking Instructions
Great care is taken to deliver your Phoroptor VRx to you intact. Please read this User’s Guide before
operating the unit.
We package the instrument in shipping containers to protect the instrument from damage during
shipping. Please carefully remove the Phoroptor Head, Controller, Central Unit, and Accessories Box
from the packaging material.
Note: Please retain the original packaging and use it if future transportation of the instrument is
required.
The main components of the Phoroptor VRx are packed in two separate boxes. The first box contains
the Phoroptor Head and Reading Rod, and the second box contains the Central Unit, Controller, and
Accessories Box.
1. Open the rst box, containing the Phoroptor Head and Reading Rod.
2. Remove the top foam layer.
3. Remove the Reading Rod. (Please refer to Figure IS-01.)
Figure IS-01, Top Foam Layer
4. Remove the second foam layer.
5. Remove the Phoroptor Head (wrapped in plastic) from the box. (Please refer to Figure IS-02.)
Figure IS-02, Packaging - Phoroptor Head
Phoroptor
Head
6. Remove the plastic wrapping from the Phoroptor Head, carefully placing the Phoroptor Head
aside with the patient side down.
7. Open the second box, containing the Central Unit, Controller, and Accessories Box.
Instrument Setup
Reading Rod
10 16241-101 Rev. D