natus Photic Stimulator User & Service Manual
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  • Page 2 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.
  • Page 3: Table Of Contents

    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 ...........................
  • Page 4: Intended Use

    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.
  • Page 5: Manual Conventions

    User & Service Manual Natus Photic Stimulator Manual Conventions Various symbols and typographical conventions are used throughout the manual. The following table illustrates them and describes their meanings and functions. Symbol / Description/Function Convention This symbol denotes a warning or important information that should not be missed.
  • Page 6: Description Of Symbols

    Natus Photic Stimulator User & Service Manual 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 Consult Accompanying Documents...
  • Page 7 User & Service Manual Natus Photic Stimulator Symbol Description CE Mark Class II Equipment (non-grounded enclosure) Electrostatically Sensitive Device (ESD)
  • Page 8: Warnings And Cautions

    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.
  • Page 9 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.
  • Page 10 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.
  • Page 11: Esd Procedures And Warnings

    User & Service Manual Natus Photic Stimulator 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.
  • Page 12: Specifications

    Natus Photic Stimulator User & Service Manual Specifications Standard Specifications Support arm 52 in. (1320.8 mm) total Frequency of flash Maximum 60 Hz Duration of flash Adjustable via Intensity control (12-position control: 11 settings; 1 Off) Intensity measured at 30cm distance, position 12: ...
  • Page 13: Environmental Conditions

    User & Service Manual Natus Photic Stimulator 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.
  • Page 14: Unpacking

    Natus Photic Stimulator User & Service Manual 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) ...
  • Page 15: Product Images

    Product Images Photic stimulator and roll stand (roll stand not included): Photic Arm:...
  • Page 16: Intensity Control, Test, Trigger In

    Natus Photic Stimulator User & Service Manual 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...
  • Page 17: Installation And Operation

    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.
  • Page 18: Recommended User Performed Maintenance

     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.
  • Page 19: Safety & Standards Conformity

    User & Service Manual Natus Photic Stimulator 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.
  • Page 20: 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.
  • Page 21: Equipment

    User & Service Manual Natus Photic Stimulator Table 4 - Immunity Test Levels - Enclosure Port Immunity Test Levels – Professional Phenomenon Basic EMC Standard or Test Method Healthcare Facility Environment Electrostatic Discharge IEC 61000-4-2 ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air...
  • Page 22 Natus Photic Stimulator User & Service Manual Immunity Test Levels – Professional Phenomenon Basic EMC Standard Healthcare Facility Environment 30% dip; 25 cycles (50Hz) Single phase: at 0° 100% dip; 250 cycles (50Hz) /300 cycles Voltage Interruptions IEC 61000-4-11 (60 Hz) Table 8 –...
  • Page 23: Table 9 - Test Specifications For Enclosure Port Immunity To Rf Wireless Communications Equipment

    User & Service Manual Natus Photic Stimulator Table 9 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Maximum IMMUNITY Band Distance frequency Service Modulation Power TEST LEVEL (MHz) (MHz) (V/m) Pulse 380 –390 TETRA 400...
  • Page 24 A Total Service Solution Standing behind every Natus product is Natus Medical Incorporated, an internationally respected innovator of medical products and services. Our Neurology systems are backed up by an in-house support team staffed with technical and clinical experts, 24/7 support, remote support via WebEx or VPN, the largest clinical and technical field support network in Neuro/Sleep and customized service contracts that include preventative maintenance visits and computer upgrades.

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