natus Photic Stimulator Troubleshooting guide

Natus Photic Stimulator User & Service Manual
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Publisher’s Notice
105706X Rev M
Natus Photic Stimulator User & Service Manual
Natus Medical Incorporated
DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville, Ontario, L6H 5S1 Canada
Tel: [phone] or Fax: [phone]
Toll Free (US & Canada): 800-303-0306
Technical Support Email: O[email protected]
Website: www.natus.com
EUROPEAN AUTHORIZED REPRESENTATIVE:
Natus Manufacturing Limited
IDA Business Park, Gort,
Co. Galway, Ireland
Tel: [phone]
Fax: [phone]
Copyright © 2018 by Natus Medical Incorporated.
Issued in December 2018.
All rights reserved. This manual contains proprietary information, which is protected by copyright
and may not be copied in whole or in part except with the prior written permission of Natus
Medical Incorporated. The copyright and the foregoing restrictions on the copyright use extend
to all media in which this information is preserved.
This copy of the User Manual shall be used only in accordance with the conditions of sale of
Natus Medical Incorporated or its distributors. Natus Medical Incorporated makes no
representations or warranties of any kind whatsoever with respect to this document. Natus
Medical Incorporated disclaims all liabilities for loss or damage arising out of the possession,
sale, or use of this document.

User & Service Manual Natus Photic Stimulator
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Table of Contents
Intended Use.................................................................................................................................................3
System components..................................................................................................................................3
Using the Manual.......................................................................................................................................3
Manual Conventions..............................................................................................................................4
Description of Symbols .................................................................................................................................5
Warnings and Cautions.................................................................................................................................7
Other warnings and cautions:....................................................................................................................7
ESD Procedures and Warnings..................................................................................................................10
Electrostatic Discharge (ESD) Handling..................................................................................................10
Specifications..............................................................................................................................................11
Environmental Conditions........................................................................................................................12
Unpacking ...................................................................................................................................................13
Product Images...........................................................................................................................................14
Photic stimulator and roll stand (roll stand not included):........................................................................14
Photic Arm:..............................................................................................................................................14
Intensity control, Test, Trigger In:............................................................................................................15
Cable Option List.....................................................................................................................................15
Installation and Operation...........................................................................................................................16
Recommended User Performed Maintenance............................................................................................17
Recommendations...................................................................................................................................17
Safety & Standards Conformity...................................................................................................................18
Essential Performance ............................................................................................................................18
Safety Standards.....................................................................................................................................18
EMC Standards .......................................................................................................................................18
Declaration of Compliance for IEC 60601-1-2:2014 (Ed. 4.0).................................................................19
Table 1 - Electromagnetic Emissions ..................................................................................................19
Table 4 - Immunity Test Levels - Enclosure Port.................................................................................20
Table 5 –Immunity Test Levels –Input A.C. Power Port....................................................................20
Table 8 –Immunity Test Levels - Signal Input / Output Parts Port .....................................................21
Table 9 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications
equipment ............................................................................................................................................22

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Intended Use
The photic stimulator is used by trained medical staff in a medical environment to apply photic flashes to
the patient during neurophysiology studies such as EEG, where it is used as an activation to test photo-
sensibility related to epilepsy. Trigger pulses applied to the input of the photic stimulator generate photic
flashes at specific frequencies, typically in the range of 0.5Hz to 60Hz. The photic stimulator is intended
for use on mobile or fixed systems, and with patients of all ages. The Photic Stimulator can also be used
along with Evoked Potential devices for stimulating Visual Evoked Potentials.
System components
Connected to Natus Neurology hardware and driven by the Natus application software from laptop,
desktop, or All-In-One computers, the Natus Photic Stimulator supplies intense flashes of light. Its
components consist of an arm-mounted light assembly, a light source, an intensity control, a test button,
and a Trigger-in receptacle for a cable from a headbox. The arm-mount has three adjustment knobs
along its length to give the unit flexibility and versatility.
Using the Manual
This manual describes the theory, features, set up, operation and maintenance of the Natus Photic
Stimulator. It also provides information on specifications, troubleshooting and getting help.
Please follow the instructions carefully.

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Manual Conventions
Various symbols and typographical conventions are used throughout the manual. The following table
illustrates them and describes their meanings and functions.
Symbol /
Convention
Description/Function
This symbol denotes a warning or important information that should not be missed.
Read all warnings and cautions carefully before starting the system for the first time.
A note that contains important supplemental information.
Bold
Names of control keys, function keys, options, and labels are shown in bold. Bold text is
also used to emphasize important names or ideas.
Italic
Italic text is used for captions.

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Description of Symbols
Symbols and warning labels on equipment can simplify language differences and give users instant
comprehension of warnings and markings in a restricted space.
Symbol
Description
ATTENTION:
Consult Accompanying Documents
or
Consult Accompanying Documents
Protective Earth (Ground)
Type B equipment
Type BF Equipment
Dangerous Voltage
Alternating Current
Power On
Power Off
Keep the Photic Lamp 0.5 meters away from walls. The Photic Arm can
rotate, which may potentially damage the Strobe Lamp.
EU only: Do Not Dispose as Unsorted Municipal Waste

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Symbol
Description
CE Mark
Class II Equipment (non-grounded enclosure)
Electrostatically Sensitive Device (ESD)

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Warnings and Cautions
This equipment/system is intended for use by Healthcare professionals ONLY. Please
read this section before installing any of the hardware. Refer to this section when you
operate, transport, store, or re-install the system.
There are no known contraindications. The photic stimulator is used at the discretion of the medical
professional.
Natus Photic Stimulator shall NOT be used in the following conditions:
Check areas of use to avoid using the system in the presence of flammable gases.
Natus systems are not AP or APG rated. DO NOT USE a Natus system in the
presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
To ensure the validity of signals, do not operate the device near any sources of
electromagnetic interference.
Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the Natus Photic Stimulator, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
Do NOT operate the system in case of damaged AC power cord or ungrounded metal
contacting damaged power cord.
Other warnings and cautions:
Natus strongly recommends that you do not open the Photic Device. It contains no
serviceable parts. If you must open the device, disconnect the power cord before you do
so.
Make sure that any platform, table, cart, or other surface used during the operation,
transport, or temporary or permanent storage of the system and its components is
adequate, sturdy, and safe. NATUS is not responsible for any injury or damage that may
result from inadequate, poorly constructed, or unapproved transports, carts, or operating
surfaces.
Never use equipment that has parts missing or equipment that might contain loose parts
inside of it (that is, inside an enclosed portion of the equipment). If you suspect a piece
of equipment has missing or loose parts, contact Natus.
Never place powered equipment (that is, equipment that operates with an electric power
source) on any flammable surface. Avoid this whether the equipment is active or not.

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Reliable grounding requires hospital-grade receptacles and power cord. Do not use
power outlets without a protective ground.
Position the equipment so that the detachable mains cord is readily accessible for
disconnection.
Always perform a leakage current test and compare to allowable standards BEFORE
connecting the patient to monitoring equipment
Do not use portable multiple socket outlets that are not properly grounded.
When an isolation transformer is used, make sure that the Medical System is properly
grounded.
NEVER connect a portable multiple-socket outlet to the isolation transformer output
receptacles. Additional cord-connected equipment may increase leakage currents and
present a hazard
Electrostatic Discharge (ESD) Precaution: Be sure to take the
appropriate Electrostatic Discharge (ESD) precautions. Disconnect the
cables before moving, cabling, or performing any set up procedures.
Connectors marked with the ESD protection symbol should not be touched.
This equipment/system may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures, such as reorienting
or relocating the equipment or shielding the location.
Use of accessories, transducers or cables other than those specified or sold by the
manufacturer on the equipment could result in increased emissions or decreased
immunity of the equipment and may cause the system to be non-compliant with the
requirements of IEC 60601-1-2 (Ed. 4.0).
Verify the power supply and all portable multiple socket-outlets are off the floor and in a
dry location.
Natus recommends proper cable management and storage to ensure stability of the
device.
Do not use the equipment adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, observe the equipment to verify normal operation in the
configuration in which it will be used.

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Electrical Fast Transients (EFT) are defined as short bursts of energy that are
propagated through the power cord. The EFT source is usually located in nearby
equipment or machinery.
EFT precautions: In environments where parasitic electrical noise interferes with
intermittent photic stimulation (IPS) there is no risk of misinterpretation of EEG
waveforms. The visual stimulation is confirmed by the technologist performing the test.
In addition the accompanying EEG (Electroencephalograph) amplifier’s signals will also
be contaminated past the point where any clinical signal interpretation is possible.
Trained electroencephalographic physicians and technologists are well equipped to
identify and disregard signals that are obscured by environmental noise.
NOTE: Natus designates no non-medical equipment for use with the Photic Stimulator
system. No supporting documentation for such devices is necessary.
NOTE: The Photic Stimulator needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided in this user
manual.
NOTE: Portable and mobile RF communications equipment can affect the functionality
of the Photic Stimulator.

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ESD Procedures and Warnings
Electrostatic Discharge (ESD) Handling
Before performing any setup or placement procedures, read the precautions outlined in this section.
WARNING: Be sure to take the appropriate Electrostatic Discharge (ESD) precautions.
Disconnect the cables before moving, cabling, or performing any set up procedures.
Some semiconductor (solid state) devices can be easily damaged by static electricity. Such
components are commonly called Electrostatically Sensitive Devices (ESD). Do not touch the
accessible conductive parts for the Connectors marked with the ESD symbol.
Follow these techniques to help reduce the incidence of component damage caused by static electricity:
Immediately before handling any product components assemblies, drain the electrostatic charge from
your body by touching a known earth ground.
Minimize body motions when handling unpackaged replacement ESDs. Motions such as brushing
clothes together or lifting your foot from a carpeted floor can generate enough static electricity to
damage the product components.
Avoid carpets in cool, dry areas. If provided, leave the product components in their anti-static
packaging until ready to be installed.
Take care when connecting or disconnecting cables. When disconnecting a cable, always pull on the
cable connector or strain-relief loop, not on the cable itself.
WARNING: A damaged cable can cause a short in the electrical circuit. Prevent
damage to the connectors by aligning connector pins before you connect the cable.
WARNING: Misaligned connector pins can cause damage to system components at
power-on.

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Specifications
Standard Specifications
Support arm
52 in. (1320.8 mm) total
Frequency of flash
Maximum 60 Hz
Duration of flash
1ms
Light intensity
Adjustable via Intensity control (12-position control: 11 settings; 1
Off)
Intensity measured at 30cm distance, position 12:
Minimum: 22000 lux
Maximum: 75000 lux
Typically an intensity of 39000 lux is observed in measurements on
Natus Photic Stimulator.
Input requirements
TTL Positive Pulse; 100 µs @ 1 mA
Mains input
100-240VAC 50/60Hz, 1 A (1A-0.5A)
Protection against electric shock:
Class I
Flammability
UL 94V-0
Environmental Conditions for Use
Operating Environmental Limits
Temperature Range
10° C to 40° C
Humidity Range
30% to 75% RH
Transport and Storage Limits
Temperature Range
-25° C to 60° C
Humidity Range
10%- 90%RH non-condensing
Condensation
Recovery Time after condensation
to operations specifications
24 hours

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Environmental Conditions
Select a room with properly grounded power sources.
Do not use or store the equipment in places where chemicals are stored or where there is a potential
for gas leakage.
Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and
temperature, poorly ventilated areas and dusty, saline or sulfuric air.
Verify the selected site maintains a relative humidity between 30% and 75% (without condensation).
Verify all conditions meet the requirements listed in the ‘Environmental Conditions for use’ section of
this manual.

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Unpacking
When you unpack your Natus Photic Stimulator, make sure the following items are included:
Photic Stimulator (p/n 10440)
Interface cable for Photic Stimulator, 20ft (p/n 003771)
Table clamp (p/n 585-PS2001C)
User & Service Manual
NOTE: The Photic Stimulator should be used only with cables that are supplied or
approved by Natus.

Product Images
Photic stimulator and roll stand (roll stand not included):
Photic Arm:

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Intensity control, Test, Trigger In:
Cable Option List
Interface cables are available with the specific end connector for the following devices:
Natus PN
Description
003771
Interface cable for Xltek
003632
Interface cable for Protektor
012788
Interface cable for Grass (Comet PLUS)
W6473H
Interface cable for Trex
019174
Interface cable for Nicolet v-series amplifiers

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Installation and Operation
WARNING: Never place the photic device on the floor.
1. Secure the photic device on a platform, table, cart, or other raised surface. Place all equipment on an
even, level surface. Avoid the potential for mechanical shock or possible vibrations during setup,
system operation, or when relocating the equipment
2. Plug the photic device only into a power outlet marked and verified as Hospital Grade.
NOTE: Acceptable ‘Hospital Grade’ power outlets must be labeled as such.
3. Depending on the amplifier hardware, connect the mini-din 6-pin male end of the appropriate
interface cable to the photic stimulator:
Use the cable with PN 003771 on NeuroWorks EEG systems with Brain Monitor, EEG32U,
EMU40EX, or Natus Quantum.
Use the cable with PN 012788 on NeuroWorks EEG systems with Grass Comet-PLUS headbox.
Connect the 2.5 mm sub-mini phone connector to the “Trigger” output and the 3.5mm mini phone
connector to the “DC1” input on the back of the amplifier system.
Use the cable with PN W6473H on NeuroWorks EEG systems with Xltek TrexHD headbox.
Use the cable with PN 019174 on NeuroWorks EEG systems with Nicolet V-32 or V-44 headbox.
NOTE: Refer to the User & Service manual of the corresponding amplifier hardware for
more information about how to connect the interface cable.
NOTE: Refer to the User manual from the EEG software Platform for more information
about how to control the Natus photic stimulator.
NOTE: Use the Test button to troubleshoot the device.

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Recommended User Performed Maintenance
To keep the Natus Photic Stimulator in good working condition, follow a regular schedule of user
performed maintenance. Regular maintenance performed by the user does not involve access to the
interior of the stimulator and components. For service problems that require corrective maintenance
and/or internal component service, call Natus Technical Support at 1-800-303-0306 or OT[email protected],
or contact your local Natus representative.
Periodically check cable connections for damage and wear. Inspect cables for bent pins. Replace frayed
or worn cables. Also, regularly inspect and clean all system components, including:
Connectors and jack ports
Accessories
The Natus Photic Stimulator and its components should not be immersed in water or any other fluid. To
clean, use a damp cloth or cleaning/disinfecting products such as isopropyl alcohol, PDI “Sani Wipes
AF3”, PDI “Sani-Cloth Plus”, Metrex CaviWipes, or AIC Wedge Wipes to wipe all surfaces, cables and
accessories.
Recommendations
Disconnect the power cord and all cables from the unit before cleaning. Use a lint-free
cloth. Do not use cleaners on any system component.
Take care not to allow any fluid to seep into the internal electronic components of the
system.
Do NOT autoclave, pressure sterilize, or gas sterilize this unit.
Do NOT soak or immerse the unit in any liquid.
A cleaning solution of 70% isopropyl alcohol is recommended.
Use cleaning solution sparingly. Excessive solution can flow into the unit and cause
damage to internal components.
Do NOT use petroleum-based or acetone solutions, or other harsh solvents, to clean the
unit.

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Safety & Standards Conformity
Essential Performance
In normal operational mode, essential performance is defined as the following:
Observe photic flash. Photic flash pattern can become random and/or irregular under immunity testing, as
long as it recovers after stimulus is removed.
Safety Standards
This device complies with the following electrical safety standards:
IEC 60601-1:Ed. 3.1 –General Requirements for Basic Safety and Essential Performance
IEC 60601-1-6:Ed. 3.1 –Collateral Standard: Usability
IEC 60601-2-40:Ed. 2.0 –Particular Requirements for the Safety of Electromyographs and Evoked
Response
ANSI Z80.36-2016 for Ophthalmics –Light Hazard Protection for Ophthalmic Instruments
EMC Standards
IEC 60601-1-2, Edition 4.0,
February 1, 2014
Medical electrical equipment –Part 1-2: General requirements for basic
safety and essential performance–collateral standard: electromagnetic
compatibility –requirements and tests
CISPR 11 ed 5.0 with A1:2010
Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment -
Electromagnetic Disturbance Characteristics - Limits and Methods of
Measurement
IEC 61000-3-2:2014, ed 4.0
Electromagnetic Compatibility (EMC) Part 3-2: Limits - Limits for
Harmonic Current Emissions
IEC 61000-3-3:2013, ed 3.0
Electromagnetic Compatibility (EMC) Part 3-3: Limits - Limitation of
Voltage Changes, Voltage Fluctuations and Flicker in Public Low-
voltage Supply Systems
IEC 61000-4-2:2008, ed 2.0
Electromagnetic Compatibility (EMC) Part 4-2: Testing and
Measurement Techniques - Electrostatic Discharge Immunity Test
IEC 61000-4-3 ed 3.0 with
A1:2007+A2:2010
Electromagnetic Compatibility (EMC) Part 4-3: Testing and
Measurement Techniques - Radiated, Radio-frequency,
Electromagnetic Field Immunity Test
IEC 61000-4-4:2012, ed 3.0
Electromagnetic Compatibility (EMC) Part 4-4: Testing and
Measurement Techniques - Electrical Fast Transient/Burst Immunity
Test
IEC 61000-4-5:2014, ed 3.0
Electromagnetic Compatibility (EMC) Part 4-5: Testing and

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Measurement Techniques - Surge Immunity Test
IEC 61000-4-6 ed 2.0 with
A1:2004 + A2:2006
Electromagnetic Compatibility (EMC) Part 4-6: Testing and
Measurement Techniques - Immunity to Conducted Disturbances,
Induced by Radio-frequency Fields
IEC 61000-4-8:2009, ed 2.0
Electromagnetic Compatibility (EMC) Part 4-8: Testing and
Measurement Techniques - Power Frequency Magnetic Field Immunity
Test
IEC 61000-4-11:2004, ed 2.0
Electromagnetic Compatibility (EMC) Part 4-11: Testing and
Measurement Techniques - Voltage Dips, Short Interruptions and
Voltage Variations Immunity Tests
Declaration of Compliance for IEC 60601-1-2:2014 (Ed. 4.0)
Table 1 - Electromagnetic Emissions
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Natus Photic Stimulator is intended for use in the electromagnetic environment specified below. The
customer or the user of the equipment should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –guidance
RF emissions
CISPR 11
Group 1
The Natus Photic Stimulator uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
The Natus Photic Stimulator is suitable for use in all establishments
other than domestic, and may be used in domestic establishments
and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes,
provided the following warning is heeded: Warning: This
equipment/system is intended for use by healthcare professionals
only. This equipment/ system may cause radio interference or may
disrupt the operation of nearby equipment. It may be necessary to
take mitigation measures, such as re-orienting or relocating the
equipment or shielding the location.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment might not
offer adequate protection to radio-frequency communication services. The user might
need to take mitigation measures, such as relocating or re-orienting the equipment.