natus Photic Stimulator Troubleshooting guide

Natus Photic Stimulator
User & Service Manual

User & Service Manual Natus Photic Stimulator
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Publisher’s Notice
EUROPEAN AUTHORIZED REPRESENTATIVE:
Natus Manufacturing Limited
IDA Business Park, Gort,
Co. Galway, Ireland
Tel: [phone]
Fax: [phone]
Copyright © 2016 by Natus Neurology Incorporated.
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 Neurology 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 Neurology
Incorporated or its distributors. Natus Neurology Incorporated makes no representations or warranties of any kind
whatsoever with respect to this document. Natus Neurology Incorporated disclaims all liabilities for loss or damage arising
out of the possession, sale, or use of this document.
105706X Rev I
Natus Photic Stimulator
Natus Medical Incorporated
DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville, Ontario, L6H 5S1 Canada
Tel: [phone] or Fax: 905 - 8 29- 5304
Tol l Free (US & Canada): 800-303-0306
Technical Support Email: [email protected]
Website: www.natus.com

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Table of Contents
INTRODUCTION 3
WARNINGS AND CAUTIONS 4
DESCRIPTION OF SYMBOLS 6
SPECIFICATIONS 7
Product Images 7
UNPACKING 8
CABLE OPTION LIST 8
INSTALLATION AND OPERATION 8
RECOMMENDED USER PERFORMED MAINTENANCE 10
Cleaning 10
Inspection 10
Maintenance 10
ENVIRONMENTAL SPECIFICATIONS 11
Temperature 11
Humidity 11
Condensation 11
Flammability 11
EMC Specifications 11
Safety Standards 12
Environmental Conditions 12
Room Topography 12
Electrostatic Discharge (ESD) Handling Procedures and Warnings 12
Electrical Fast Transient (EFT) Procedures and Warnings 13
Declaration of Compliance for IEC 60601-1-2:2007 14

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Introduction
The Natus Photic Stimulator is a powerful, portable option that can enhance and expand
neurologic testing. Driven by the Natus NeuroWorksTM software from laptop or desktop
computers, it 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.

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Warnings and Cautions
Important Safety Information
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.
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. XLTEK 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 XLTEK.
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.
A risk of explosion is possible if you use this device in the presence of flammable
anesthetics.
Reliable grounding requires hospital-grade receptacles and power cord.
Always perform a leakage current test and compare to allowable standards BEFORE
connecting the patient to monitoring equipment
NEVER connect a multiple portable socket outlet to the isolation transformer output
receptacles. Additional cord connected equipment may increase leakage currents and
present a hazard.
XLTEK strongly recommends that you do not open the Photic Device. It contains no
serviceable parts. If you must open the device, disconnect the line cord before you do
so.
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 cables other than those specified or sold by the manufacturer on the
equipment, may result in increased emissions or decreased immunity of the
equipment and may cause the system to be non-compliant with the requirements of
IEC 60601-1-2:2007

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The equipment should not be used adjacent to or stacked with other equipment and
that if adjacent or stacked use is necessary, the equipment should be observed to
verify normal operation in the configuration in which it will be used.
Fast transients precautions (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: XLTEK designates no non-medical equipment for use with the Photic Stimulator
system. No supporting documentation for such devices is necessary.
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.
Portable and mobile RF communications equipment can affect the functionality of the
Photic Stimulator.

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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.
ATTENTION:
Consult Accompanying Documents
Consult Accompanying Documents
Protective Earth (Ground)
Type B equipment
Type BF Equipment
Dangerous Voltage
Alternating Current
Power On
Power Off
EU only: Do Not Dispose as Unsorted Municipal Waste
CE Mark
Class II Equipment (non-grounded enclosure)
Electrostatically Sensitive Device (ESD)

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Specifications
WARNING: Reliable grounding requires hospital-grade receptacles and power cord.
Support arm
52 in. (1320.8 mm) total
Frequency of flash
Maximum 60 Hz
Light intensity
Adjustable via Intensity control (12-position control: 11 settings; 1 Off)
Input requirements
TTL Positive Pulse; 100 s @ 1 mA
Mains input
100-240VAC 50/60Hz, 1 A (1A-0.5A)
Protection against electric shock: Class I
Product Images
Photic Arm: Intensity control, Test, Trigger In

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Unpacking
When you unpack your Natus Photic Stimulator, make sure the following items are included:
Photic Stimulator (p/n 10440)
PCI to Photic Stimulator 20ft Cable (p/n 003771)
Protektor to Photic Stimulator Cable (p/n 003632)
User & Service Manual
NOTE: The Photic Stimulator should be used only with cables, transducers, electrodes,
sensor, and switches that are supplied or approved by XLTEK.
Cable Option List
The 20ft cables are available with the specific end connector for the following devices:
Xltek PN
Description
003771
PCI to Photic Stimulator Cable
003632
Protektor to Photic Stimulator Cable
012788
Photic Stimulator –Grass Amplifiers Cable
W6473H
Trex Cable for LED Photic Stimulator
580-PHTCB1
Photic Stimulator –Netlink Cable
580-PHTCB3
Photic Stimulator –XL Cable
Installation and Operation
WARNING: Never place the photic device on the floor.
1) Place the photic device on a platform, table, cart, or other raised surface.
Never place the photic device on the floor.
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) On the XLTEK Connex, Brain Monitor, Brain Monitor ICU, EEG32U or EMU40 headbox,
connect the mini-din 6-pin male end of trigger cable (XLTEK part number 003771) to the
Photic connector.
4) On the XLTEK Trex headbox, connect the Hirose connector of trigger cable (XLTEK part
number W6473H) to the Photic connector.
5) On the XLTEK PCI computer-headbox interface card (used with EEG32, EMU40,
EMU128FS, Mobee and Hyppo headboxes), connect the mini-din 4-pin male end of trigger
cable (XLTEK part number 003771) to the matching connector on the PCI card.

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6) On the Netlink or Netlink ICU headbox, connect the mini-din 4-pin male end of trigger cable
(BLSC part number 580-PHTCB1) to the Trig I/O connector.
7) On the Netlink LTM or XL headbox, connect the Lemo 6-pin connector of trigger cable
(BLSC part number 580-PHTCB3) to the Auxiliary connector.
8) On the Gamma headbox, connect the phone plug of trigger cable (BLSC part number 580-
PHTCB2) labeled “Strobe Out” to the phone jack on back panel of computer labeled “Strobe”.
9) Use the photic device per the instructions in the NeuroWorks User & Service Manual (part
number 101886X).
10) On the Grass Comet-PLUS amplifier, 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.
OR
11) Use the Test button to troubleshoot the device.

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Recommended User Performed Maintenance
Cleaning
No special cleaning is required for this device. Ordinary, ‘house-keeping’ type cleaning to prevent
the accumulation of dust or debris is adequate.
Inspection
No special inspection procedures are required for this device.
Maintenance
This device has no serviceable parts and requires no scheduled maintenance.

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Environmental Specifications
Temperature
Operating: 10 to 40° C
Storage and transportation: -20 to 70° C
Humidity
Operating: 30% to 75% RH
Storage and transportation: 10%- 90%RH non-condensing
Condensation
Recovery Time after condensation to operations specifications: 24 hours
Flammability
UL94 HB
UL94V-O
EMC Specifications
IEC 60601-1-2:2007 Electromagnetic Compatibility (EMC) Testing
CISPR 11 B Conducted and CISPR 11A Radiated Emissions
EN 61000-4-2 Electrostatic Discharge Test
EN 61000-4-3 Radiated Susceptibility Test
EN 61000-4-4 Transient Susceptibility Test
EN 61000-4-5 Surge Susceptibility Test
EN 61000-4-6 Conducted Immunity Test
EN 61000-4-8 Magnetic Fields Test
EN 61000-4-11 Voltage Fluctuations Test
EN 61000-3-2 and EN 61000-3-3 Dips and Flicker Test
RE 101 Magnetic Emissions Test

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Safety Standards
This component complies with the following electrical safety standards:
UL 60601-1
CAN/CSA C22.2 No. 601-1-M90
IEC 60601-1-2:2007 Electromagnetic Compatibility (EMC) Testing
Environmental Conditions
Select a room with properly grounded power sources.
Do not use or store your 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 Specifications section
of this manual.
Room Topography
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.
Verify the power supply and all portable multiple socket-outlets are off the floor and in a
dry location.
Electrostatic Discharge (ESD) Handling Procedures
and Warnings
Before performing any setup or placement procedures, it is recommended that all clinical staff
read and/or are trained on 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 or pins for the Connectors marked with the ESD symbol unless ESD
precautionary procedures are used.

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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.
Electrical Fast Transient (EFT) Procedures and Warnings
Electrical Fast transients are defined as short bursts of energy that are propagated through the
power cord. The EFT source is usually located in the nearby equipment or machinery such as
motors switching equipment light switches, etc.
The functionality of Some Semiconductor devices and high sensitivity amplifiers (EEG, EMG
ECG) may be affected by EFT.
For higher levels of EFT - the effect could be described as noise on the EEG waveforms or visible
variance in the stimulating pattern.
Follow these techniques to help identify the sources and reduce the effect of the EFT:
Verify the power supply and all portable multiple socket-outlets are off the floor and in a dry
location.
Verify the Power cord integrity, do not use portable multiple socket outlets that are not
properly grounded.
Do not use the power outlets without a protective ground
When isolation transformers are used, make sure that the Medical System is properly
grounded.
If the effect of the EFT is present on EEG waveforms and visual stimulators try to identify the
nearby possible equipment by disconnecting it from the common power source

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Declaration of Compliance for IEC 60601-1-2:2007
IEC 60601-1-2:2007 Table 1 Requirements
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

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IEC 60601-1-2:2007 Table 2 Requirements:
The Natus Photic Stimulator is intended for use in the electromagnetic environment specified
below. The customer or the user of the Natus Photic Stimulator should assure that it is used in
such an environment.
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±0.3 kV contact
±8 kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines ±1
kV for
input/output lines
± 0.5kV was
applied and unit
still flickered.
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
±1 kV line(s) to
line(s) ±2 kV
line(s) to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
UT = 100Vac &
240 Vac
<5 % UT
(>95 % dip in
UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 %UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT)
for 5 sec
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT)
for 5 sec
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the equipment requires
continued operation during power
mains interruptions, it is
recommended that the equipment
be powered from an
uninterruptible power supply or a
battery.
Power frequency
(50 Hz) magnetic
field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.

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IEC 60601-1-2:2007 Table 4 Requirements:
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.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment –guidance
Conducted RF
IEC 61000-4-6
Radiated RF IEC
61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m 80 MHz
to 2,5 GHz
3 Vrms
1 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the equipment
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m). Field strengths from fixed RF
transmitters, as determined by an electromagnetic
site surveyashould be less than the compliance level
in each frequency rangeb
Interference may occur in the vicinity of known RF
transmitting devices and equipment marked with the
following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF
compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the equipment
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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IEC 60601-1-2:2007 Table 6 Requirements:
Recommended separation distances between
portable and mobile RF communications equipment and the Natus Photic Stimulator
The Natus Photic Stimulator is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Natus Photic Stimulator can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Natus Photic Stimulator as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum output
power
of transmitter
W
Separation distance according to frequency of transmitter
M
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12
0.35
0.70
0.1
0.37
1.11
2.21
1
1.17
3.50
7.00
10
3.69
11.07
22.14
Note: Table 6 above is for a field strength (E1) of 1V/m and Vrms (V1) of 3V.

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