EDI VERIS EMS IV Supplement

VERIS
™
Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 1 of 16
VERIS™
FMS IV / EMS IV Stimulators
Installation &
Service Manual
Release D
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Electro-Diagnostic Imaging, Inc.
http://www.veris-edi.com
Tel [phone]
Fax [phone]
Email: [email protected]
0413

VERIS™ Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 2 of 16

TableofContents
1. IntendedUse,RegulatoryInformation,WarningsandPrecautions..........................................3
1.1. IntendedUse 3
1.2. Contraindications 3
1.3. RegulatoryInformation 3
1.4. WarningsandPrecautions 3
2. Labels....................................................................................................................................................................5
2.1. ComponentLabels 5
2.2. ShippingLabel 5
3. UserProfile.........................................................................................................................................................6
4. ProductLifetime...............................................................................................................................................6
5. ComponentsoftheFMSIV/EMSIVStimulators...............................................................................6
6. TheoryofOperation.......................................................................................................................................6
7. Specifications.....................................................................................................................................................6
8. Installation..........................................................................................................................................................8
9. LuminanceCalibration...............................................................................................................................10
10. GridCalibration.............................................................................................................................................11
11. PreventiveMaintenance............................................................................................................................12
12. Troubleshooting&Repair.........................................................................................................................13
13. Parts...................................................................................................................................................................14
14. Cables,Schematics&Diagrams..............................................................................................................15
15. Software............................................................................................................................................................16
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VERIS
™
Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 3 of 16
1. Intended Use, Regulatory Information, Warnings and Precautions
1.1. Intended Use
The VERIS system is an electrodiagnostic device used to generate photic signals and to
measure and display the electrical signals generated by the retina and the visual nervous
system. It displays digitized electroretinogram (ERG) and visual evoked potential (VEP)
signals, power spectra and topographic maps. These functions are controlled and interpreted
by trained medical professionals. The device is intended for use in the diagnosis and
management of diseases affecting the function of the retina and the visual pathway.
1.2.
Contraindications
VERIS should not be used unless clinically indicated or in research with an IRB approved
protocol.
1.3.
Regulatory Information
VERIS Systems are in compliance with:
FDA - 21 CFR Part 820 - Quality System Regulations
ISO 13485 - Quality Management Systems - Requirements for regulatory purposes
ISO 14971 - Medical Devices - Application of Risk Management to Medical Devices
IEC 60601-1 - Medical Electrical Equipment - Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-2 - Medical Electrical Equipment - Part 2: General requirements for basic
safety and essential performance - collateral standard: Electromagnetic
VERIS has been tested for radiative emissions and shown to meet the requirements for a
Class A medical device.
1.4.
Warnings and Precautions
Read this manually carefully before using the VERIS System.
WARNING: To avoid risk of electric shock, this equipment must only be connected to
electrical supply mains with protective earth.
WARNING: To avoid risk of explosion, do not operate the isolation power supply in the
presence of flammable anesthetics or other flammable gases or liquids.
WARNING: Do not operate the isolation power supply on the floor.
WARNING: Do not connect additional multiple outlet devices or extension cords to the
system.
WARNING: Do not connect any device(s) not approved by EDI to the multiple socket
outlets of the isolation power supply.
WARNING: Unauthorized modifications to the VERIS hardware and / or software void the
warranty and may increase the risk of injury to patient and/or operator.
WARNING: All servicing to be undertaken only by qualified personnel. There are no user
serviceable parts inside the unit.
CAUTION: If corneal electrodes are used for data acquisition, follow all instructions
provided by the manufacturer and appropriate regulatory agencies for the use, cleaning,
disinfection, and maintenance of these electrodes.

VERIS
™
Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 4 of 16
CAUTION: Carefully adhere to best medical practices whenever administering medication
for mydriasis and/or corneal anesthesia. These include proper instructions to the patient,
administration of eye medication, additional care in the event of adverse reactions, and
provision of and/or use of dark glasses after testing.
WARNING: Perform system calibrations as described in this manual at intervals of 2-3
months.
WARNING - Some normative sample data as well as some patient data are provided for some
of the protocols. They are meant for illustration only. Users are encouraged to collect their
own normative data and use VERIS protocols for the statistical analysis.
WARNING - Backup the computer records on a regular basis to prevent the loss of patient
data.
WARNING - The VERIS System in its complete configuration has been tested to meet the
requirements for hospital use in the United States, Canada and Europe. If the VERIS System
is used with customer provided components, testing for safety is the responsibility of the
customer.
Do not sit on the cart or table
.
CAUTION: Federal law restricts the medical use of this device on the order of a physician or
a properly licensed practitioner.
CAUTION: To reduce risk of exposure to airborne pathogens, clean Fresnel lenses, acrylic
screens, and painted surfaces of stimulators with a soft cotton cloth and anti-bacterial window
cleaning solution or alcohol swabs prior to each use.
WARNING: Clean the outside of the objective lens of the FMS and EMS stimulators ONLY
with a high quality lens cleaner and a clean, soft cloth. Antibacterial soft, absorbent
micropore cloth may be used with the lens cleaner. Do not, under any circumstances, remove
this lens from the stimulator.
Recording electrodes can transfer pathogens between patients. Disinfect reusable electrodes
between patients according to manufacturers instructions.
Single use electrodes must be disposed of as biohazardous medical waste.
Recycle electronic equipment after end of life according to local laws and regulations

VERIS
™
Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 5 of 16
2. Labels
2.1. Component Labels
2.2. Shipping Label
Electro-Diagnostic Imaging, Inc.
1551 McCarthy Blvd.,
Milpitas, CA 95035
Made in USA
Electro-Diagnostic Imaging, Inc.
1551 McCarthy Blvd.,
Milpitas, CA 95035
Made in USA
Electro-Diagnostic Imaging, Inc.
1551 McCarthy Blvd.,
Milpitas, CA 95035
Made in USA
Electro-Diagnostic Imaging, Inc.
1551 McCarthy Blvd.,
Milpitas, CA 95035
Made in USA
Electro-Diagnostic Imaging, Inc.
1551 McCarthy Blvd.,
Milpitas, CA 95035
Made in USA
Electro-Diagnostic Imaging, Inc.
1551 McCarthy Blvd.,
Milpitas, CA 95035
Made in USA
Electro-Diagnostic Imaging, Inc.
1551 McCarthy Blvd., Suite 114,
Milpitas, CA 95035, USA
T: +1 (650) 631 – 0120
F: +1 (650) 631 – 0122

VERIS™ Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 6 of 16
3. User Profile
Users of the system include physicians, scientists, and other medical or scientific personnel
trained or otherwise experienced in visual electrophysiological testing.
4. Product Lifetime: The product lifetime is 5 years
5. Components of the FMS IV / EMS IV Stimulators
FMS IV or EMS IV stimulator unit
Controller
Articulating Arm
Spot Calibrator
Calibrator Adapter
Grid Calibrator
Connecting cables
6. Theory of operation
The FMS and EMS IV stimulators create programmable visual pattern stimulation covering the
central 45°of the visual field. Both units incorporate an infra-red (IR) video eye camera for patient
alignment to the refraction system of the unit and for monitoring the patient's fixation stability. The
FMS IV contains an IR video fundus camera for monitoring fixation position and stability
throughout the data collection. Both units provide single knob spherical refractive correction with a
range of -20 to +8 diopters.
7. Specifications
Physical
Stimulator unit
Approx. 18-21” x 7” x 4.25” (46-54 cm x 19cm x 6.7 cm) powder coated upon aluminum
housing
Note: without mounting plate; variable length depends upon focus
Approx. 8 lbs (3.63 Kg)
Controller
Approx. 7” x 4.5” x 2” (18cm x 11.5cm x 5cm)
Operating Environment
The FMS IV and EMS IV are designed for use in a typical office, scientific laboratory or hospital
environment.
Maximum Operating Altitude: 10,000 feet (3,048 meters)
Operating Temperature: 20° to 32° C
Relative Humidity: 0% to 80% non-condensing
Atmospheric Pressure: 75-105 kPa
The maximum combined power drawn from the multiple outlets of the isolation power supply and
its internal DC power supplies must not exceed the rating of the Toroid transformer. Any
additional devices powered by these outlets become part of the medical equipment and can thus
reduce the level of safety of the VERIS system.
Shipping / Storage Specifications
Shipping Altitude: 35,000 feet (10,668 meters)
Storage Temperature: -50° to +90° deg C
Maximum Storage Altitude: 15,000 feet (4,572 meters)
Relative Humidity: 0% to 90% non-condensing

VERIS™ Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 7 of 16
Power Consumption (at max luminance)
+12 VDC 1.5 A
+24 VDC 0.5A
Performance and Operating Specifications
Internal high-resolution, color, LCOS stimulus display
1280 x 1024 pixels at 60 Hz, 75 Hz, or 85 Hz
40 microsecond response time
24-bit RGB color (8 bits per channel)
LED life expectancy of 1,000 hours
Red: 627 nm typical, half-width 20 nm at 350 mA and 25 °C
Green: 530 nm typical, half-width 30nm at 350 mA and 25 °C
Blue: 470 nm typical, half-width 20nm at 350 mA and 25 °C
Approximately 50 degree diameter field of stimulation.
Greater than 300 cd/m2 maximum luminance.
Infrared Video Eye Monitoring (FMS IV and EMS IV)
Both use IR LEDs: 850 nm dominant wavelength; half-width 45 nm at ½ intensity
Eye camera provides magnified IR image of eye for accurate alignment and monitoring
during testing.
Infrared fundus camera provides IR fundus image for accurate fixation monitoring during
testing.
Software provides for capturing and saving single frames of the fundus image. Recorded
waveform traces later can be easily superimposed upon saved fundus image images.
Patient Refraction System
Single-knob correction of spherical refractive errors with automatic compensation for
magnification/minification stimulus on the subject's retina
oMaximum myopic correction: -20 D SPH
oMaximum hyperopic correction: +8 D SPH
Stimulator is mounted on an articulated arm for easy positioning (arm included).
Spot Calibrator mounts on refractor lens for convenient re-calibration using VERIS
software The Spot Calibrator is included in every Veris™ platform
Fixation monitoring with IR fundus camera (with FMS stimulators only)
Stimulator incorporates an IR fundus camera and an IR illumination system of the fundus
Fundus illumination uses IR LEDs at 850 nm dominant wavelength with 45 nm half-
width.
The camera lens has an adjustable aperture.
A Grid Calibrator is included with every FMS installation. It is a model eye that allows
calibration of the stimulus grid shown overlayed over the video fundus image.

VERIS
™
Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 8 of 16
8. Installation
Note: Installation and connections of the FMS IV and the EMS IV are the same.
Carefully unpack the FMS IV/EMS shipping carton and the carton containing the light articulated
arm. If either box is damaged, notify the carrier and EDI immediately. Check the content of each
box against its packing slip when it is opened to account for all items.
Mount the arm on the right
front edge of the desktop.
Mount the Control Box to
the left of the Arm Mount.
Mount the tilting mechanism with the four
small screws that you find in the attached bag.
Note the orientation of the plate. The access
hole for the adjustment of the focusing break
must be toward the back of the unit.
Mount the articulating arm on the side next to the control box. Insert the tilting mechanism of the
stimulator unit into the end of the arm.
Rearmount
Large
Steelpad

VERIS
™
Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 9 of 16
Adjust the articulating arm so that it freely floats the stimulator for easy positioning.
Hold adjustments can be used
to prevent unwanted arm
movements. Wrenches for the
adjustments are included with
the arm.
Connect the cables
IMPORTANT: Observe the keyed orientation of the black LVDS connector to the Controller.
Use the included DVI-to-Thunderbolt adapter to connect the DVI cable to a computer with
Thunderbolt ports.
Connect the gray 5-pin Cable 31-02 (blue dot) from the rear of the FMS Control Box to the DIN
connector (blue dot) at the upper left corner of the Switchbox labeled "FMS Power Out".
The GearMo serial adapter connects directly to the control box serial port and to the serial port of the
Grass 15LT amplifier. If replacing a previously installed Keyspan Adapter, it will be necessary
to install the GearMo driver.
Connect the VGA connector of the long grey cable (FMSIV-Cable-76) to the matching connector on
the back of the black display tube of the FMS IV. The other end is connected to the VGA connector
of the switchbox. Older switchboxes that lack a VGA port require a Cable 76 having a DIN
connector and RCA plug in place of one VGA connector. Call EDI for assistance in this
situation.
Switchbox FMS
Controlle
r
FMS IV
or
EMS IV
Serial
Adapte
r
Computer
USB port
LVDS
Cable 76
DVI
Cable 31
Thunderbolt port
FMS / EMS IV Block Schematic
Holdadjustments
Smallwrench
StimulatorArmAdjustments
Largewrench

VERIS
™
Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 10 of 16
9. Stimulus Luminance Calibration (FMS IV and EMS IV Stimulators)
Luminance calibration of the EMS IV/ FMS IV microdisplay requires a calibrated Spot Calibrator
with Eye Camera Calibrator Adapter (ECCA). These components are provided with every Veris™
platform.
Measuring the Calibrator Dark Current
1. Connect the FMS/EMS controller to the existing Veris system.
2. Power up the computer.
3. Turn on the power switch on the Controller.
4. Connect the calibrator’s 25-pin connector of the Spot
Calibrator to the socket labeled “Auto-calibrator” on the
VERIS interface box. A spot calibrator is provided with every
Veris™ platform.
5. Start VERIS™, open a protocol that uses the stimulator and
select a plot.
6. From Calibration on the menu bar select Calibrator Calibration
and make sure Spot Calibrator is Checked
7. Cover the opening of the calibrator to keep the sensor in
complete darkness.
8. Click on Read, wait until the the reading is reasonably stable,
click stop and accept the reading of the dark current.
9. Slide the calibrator sensor with the Calibrator Adapter (ECCA) attached from the top over the
front lens of the stimulator.
10. From Calibration on the menu bar select Autocalibration, press start and wait until the process is
finished.
11. The three curves shown must be monotonically increasing
toward the right and look similar to those in the figure shown
here. If this is verified, you may accept
the calibration.
Spot Calibrator with
ECCA attached
Spot Calibrator (right) with
E
y
e Camera Calibrator Ada
p
ter
(
le
f
t
)

VERIS™ Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 11 of 16
10. Stimulus Grid Calibration (FMS Stimulators only)
The retina does not reflect enough light to make it possible to see the stimulus in the IR fundus
image. To make it possible for the operator to monitor where the subject is fixating on the multifocal
stimulus array, Veris™ overlays an outline of the stimulus grid on the fundus image. This grid must
be calibrated to match the actual stimulus. This is achieved using a model eye (Grid Calibrator) with
a highly reflective fundus using the following procedure:
1. With a test subject folder open, select the protocol containing the words ‘for grid calibration’.
from the "FMS Microdisplay" Analysis Settings folder.
2. Open a recording window.
3. Place the Grid Calibrator on the FMS
front lens.
4. Turn off IR illumination with the toggle
switch at the back of the black
microdisplay tube.
5. Select the fundus camera by toggling the up or down arrow keys of the computer keyboard.
6. Double-click on the fundus image in the window to open the camera controls.
7. Adjust the image brightness by means of and contrast controls and by rotating the Grid Calibrator
as necessary. Fluctuations of image brightness are normal. If you can still not see the stimulus
well enough, you may open the lens aperture. To do so, move the camera back out of the FMS IV
housing using the focusing knob until the black aperture lever is accessible.
8. Focus the video image
9. Open the "Stimulus" tab of the camera
control window and adjust the size and
position of the grid to match the stimulus as
closely as possible. (Holding the "shift"
key down on the keyboard while clicking
on the size and position controls produces
larger changes.)
10. Click OK to exit from the controls dialog,
then exit from the recording window when
the grid matches the stimulus as closely as
possible. Contact EDI if a satisfactory
match cannot be achieved.
11. Reposition the CCD camera aperture to the
position you normally use for fundus monitoring and switch the IR fundus illumination back on.
This calibration will be correct for any multifocal stimulus array and for any refractive
correction.
EDI recommends repeating this procedure every 3-4 months or whenever a new version of the
software has been installed.

VERIS™ Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 12 of 16
11. Preventive Maintenance
The only areas accessible for field service are external. Internal adjustments of the optics require
special tools and must be performed by qualified engineers at the factory.
Do NOT open the stimulator housing for any reason. There are no user-serviceable
parts inside.
User Maintenance
1. Painted external surfaces of the stimulators may be cleaned with a soft cotton cloth or
standard alcohol pads.
2. Avoid touching the large eye lens. Apply lens cover when the instrument is not in use.
If necessary, clean lens with eyeglass cleaning materials and soft cotton or micropore
cloth.
3. Calibration
Perform Grid Calibration and Auto-Calibration at periodic intervals of less than three
months and after updates to the VERIS software. Instructions are found below and in
the VERIS User Manuals.
4. VERIS™ application software updates are provided from the EDI website free of charge
within the first year. Instructions for updating the software are provided in the "Release
Notes" file included with the updated software. After one year, an annual service fee is
charged. A surcharge may be added and a new key file may be required for major
updates. Contact EDI for details.

VERIS™ Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 13 of 16
12. Troubleshooting & Repair
There are no field serviceable parts within any of the VERIS™stimulators. See "Troubleshooting"
below in the event of a malfunction. If problem persists, contact EDI.
Do NOT open the stimulator housing for any reason. There are no user-serviceable parts inside.
Problem Diagnostic Test Finding Conclusion
Message:
VERIS™ does
not have a serial
port connection
to the
microdisplay
Make sure microdisplay power
is on. If the problem persists, contact EDI
Check connections microdisplay
control box - Keyspan adapter -
USB port of computer.
Switch the microdisplay control
box OFF, wait, then and ON
again. Then run VERIS and
enter a recording window. It
may be necessary to try twice to
enter recording.
Message: This
computer does
not have a
video monitor
for recording
Check Displays preferences.
Make sure video mirroring is
turned off.
Select Detect Displays
The second monitor should
show in the Monitors
Preferences at resolution
1280 x 1024.
If the problem persists,
contact EDI
No video
images in
recording
window; either
eye camera or
fundus camera
Check the firewire cable at the
back of the computer. Make
sure it is plugged into the rear
firewire port.
Check Camera Cable
connections to stimulator and
switchbox.
If problem persists,
contact EDI

VERIS™ Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 14 of 16
13. Parts
Current (2015 and later)
ITEM Model / Part # Source
*FMS IV or
*EMS IV Stimulator FMSIV-TPI EMSIV EDI
1 Tilter Assembly EDI
1 EMS/FMS Control Box SA-ContBox-05 Forth Dimension Displays / EDI
1 5-pin DC Power Cable Cable-31-02 EDI
1 USB/RS232 adapter USB ADAPTER-02 GearMo
1 Interface Cable Cable-76-02 or
Cable-76-6FT Cables-to-Go
1 Mini display/DVI adapter Adapter-03 Apple Computers
1 Stimulator Arm (Light) IOP7500-500-124 EDI
1 Spot Calibrator CAL-Spot-01 International Light / EDI
1 Grid Calibrator CAL-GRID-02 EDI
1 Calibrator Adapter CA EDI
Legacy ITEM Model / Part # Source
1 Camera Interface Cable Cable-76-01 EDI
1 Keyspan USB adapter Keyspan Model # USA-28XG Any Vendor
1 EDI Serial Cable Cable-34-01 EDI
* Part pricing varies. Contact EDI for current pricing information.
FMS IV on Arm EMS IV on Arm EMS/FMS Controller
Keyspan USB Adapter
(Legacy)
Grid Calibrator
Spot Calibrator with
(CA) Adapter

VERIS
™
Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 15 of 16
14. Cables, Schematics & Diagrams
Calibrator DB-25 Connector
Cable 76-02 and 76-6FT (Standard Male-Male VGA)
Legacy Cables
Cable 76-01 (Camera Interface Cable)
Serial Assembly (Keyspan Adapter and Cable 34-01)
1224 25
Gnd
Cal Out + 5vdc
Gnd
Keyspan
USB/Serial
Adapter

VERIS™ Service Manual EMS & FMS Stimulators
VG-119-D / 21-Jan-2017 Page 16 of 16
15. Software
All stimulator functions are controlled by the VERIS™ application software.