Natus Additional Information and Safety Reference Guide Rev 10 March 2013

Additional Information and Safety Notes Manufacturer...2 European Authorized Representative ...2 CE Mark...2 Technical support ...2 Safety Summary...3 U.S. Patents ...3 Service manuals for your system...4 Specifications Nicolet Brand systems...5 Ergonomic environment responsibilities...5 Preventive maintenance ...6 Cleaning, disinfection and sterilization of parts in contact with the patient ...7 Safety notes...9 General safety notes ...9 Electrical shock (line voltage)...12 Data misinterpretation, corruption, loss, false positives, false negatives, etc. ...13 Physical injury...15 Amplifier arm ...15 Electrodes and transducers ...15 Electrical stimulators for Nicolet EDX, Nicolet Endeavor, Nicolet VikingSelect, Nicolet VikingQuest, Synergy Focus and Synergy Plinth and PIU ...17 Auditory stimulator for Nicolet EDX, Nicolet Endeavor, Nicolet VikingSelect, Nicolet VikingQuest, Synergy Focus and Synergy Plinth ...18 Bovie / Electrocautery ...19 Implant electrodes ...20 EMG ...20 Leakage current ...20 Batteries...21 Recycling / disposal ...21 Defibrillation ...22 Mains operated equipment with additional power supply ...22 Replacement of fuses and other parts...22 Hard drive...22 Restricted environmental conditions for operation, transport and storage...23 Electrodes and Amplifiers...24 Isolation / Isolation transformer ...25 Software ...26 Electromagnetic Compatibility (EMC) Information ...27 ESD handling ...28 Networking...29 Operating environment...30 System connections ...31

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Natus Neurology Incorporated Product Specific Cautions and Warnings ...33 Nicolet cEEG, Nicolet nEEG / LTM, Nicolet Monitor, and Nicolet vEEG ...33 Nicolet Endeavor and Nicolet Endeavor CR...36 Nicolet EDX, Nicolet VikingQuest, Nicolet VikingSelect, Synergy Focus, Synergy Plinth and PIU ...37 Nicolet Ambulatory EEG ...39 Nicolet 2015 Visual Stimulator...39 NONIN Pulse Oximeters...40 Typical international symbols ...43 Publication EN 980 Symbols ...46 Publication IEC 417 Symbols ...47 Publication TR 60878 Symbols ...48 Directive 2002/96/EC symbols ...48 Miscellaneous symbols ...48 Typical symbols on Nicolet Brand systems ...49 Example Nicolet Brand labels ...55 Example Nicolet Brand voltage labels ...57

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Additional Information and Safety Notes This publication contains information applicable to the following Nicolet Brand products: • Nicolet Endeavor • Nicolet Endeavor CR • Nicolet cEEG • Nicolet nEEG & LTM • Nicolet Monitor • Nicolet vEEG • Nicolet VikingQuest • Nicolet VikingSelect • Nicolet 2015 Visual Stimulator • Nicolet Ambulatory EEG • NONIN Pulse Oximeter • Nicolet EDX • Synergy Focus • Synergy Plinth and PIU • Nicolet EEGwireless32/64 Amplifier • Nicolet Cortical Stimulator Global Cautions and Warnings applicable to the above products are combined in the first section of this publication. Specific Nicolet Brand products Cautions and Warnings are located towards the end of this publication. Please read this publication entirely before applying power to your Nicolet Brand system. Information in this publication may be changed without notice. Natus Neurology Incorporated 1850 Deming Way Middleton, Wisconsin USA 53562-3530 Tel: 608-829-8500 Toll free: 1-800-356-0007 Internet: www.natus.com

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Natus Neurology Incorporated

Manufacturer Natus Neurology Incorporated 1850 Deming Way Middleton, WI USA 53562 608-829-8500 1 800-356-0007 Fax: 608-829-8589 www.natus.com

European Authorized Representative Natus Europe GmbH Robert-Koch-Str. 1 82152 Planegg Germany

CE Mark Compliant to Neurology Device Directive 93/42/EEC

Technical support Domestic Natus Neurology Incorporated 1850 Deming Way Middleton, WI USA 53562 1-800-356-0007 [email protected] www.Natus.com

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International Natus Neurology Incorporated Phone: 0049 (0) 180 501 5544 Fax: 0049 (0) 89 83942777 [email protected] www.Natus.com

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Additional Information and Safety Notes

Safety Summary In this guide, two labels identify potentially dangerous or destructive conditions and procedures:

The WARNING label identifies conditions or practices that may present danger to the patient and/or user. The CAUTION label identifies conditions or practices that could result in damage to the equipment.

U.S. Patents The following U.S. Patent Number(s) apply to each applicable Nicolet Brand products. U.S. Patent Numbers 6,366,805, 4,816,813 6,463,322 6,735,711

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Service manuals for your system A Service manual which contains servicing information that Natus Neurology Incorporated has deemed as appropriate for those parts of your system designated as repairable is available. The Service manual is intended for use only by qualified and trained technical personnel. A charge will be applied for the Service manual. Natus Neurology Incorporated 1850 Deming Way Middleton, Wisconsin USA 53562-3530 Tel: 608-829-8500 Toll free: 1-800-356-0007 World Wide Web: www:natus.com

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Additional Information and Safety Notes

Specifications Nicolet Brand systems Specifications are available from Natus Neurology Incorporated for your system.

Ergonomic environment responsibilities The ergonomic environment surrounding the system or cart may contribute to product risk. It is the responsibility of each institution to ensure users are in a position that meets its human factors/ergonomics/safety requirements.

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Preventive maintenance aa-01 Electrical safety testing is recommended. It is recommended a schedule be established for these purposes, with at least an annual cleaning and safety testing. This system does not require calibration unless otherwise stated. aa-02 Preventative maintenance does not require access to the interior of the instrument and may be performed by the user. For this device, preventative maintenance consists of periodically cleaning and inspecting the exterior of the instrument. aa-03 Cleaning consists of removing all dust from the exterior surface of the system with a soft brush or cloth. Use a brush to dislodge any dirt on or around the connectors and panel edges. Remove any dirt with a soft cloth, slightly dampened with a mild detergent solution or cold sterilization agent. aa-04 Turn OFF system power before cleaning. Prevent detergent solution or cold disinfecting agents from seeping into the electronics of the instrument. Be especially careful around controls, connectors and edge panels. Do not use abrasive cleaners. aa-05 It is recommended that all repairs be performed by a qualified Natus Neurology Incorporated service representative only. You have the sole responsibility for any malfunctions resulting from improper maintenance or repair by anyone other than an authorized Natus Neurology Incorporated representative. aa-06 If the system is not functioning properly, do not operate it until all necessary repairs are made and unit is tested for proper functioning in accordance with Natus Neurology Incorporated published specifications. It is recommended that all repairs be performed by a qualified service representative only. aa-07 See the following Safety Summaries in this publication for additional safety considerations. aa-08 Switch off all power to the system before attempting any service, maintenance, or preventive maintenance. aa-09 If the system or any component is repaired, it is recommended that all system functionality be checked and an electrical safety test be performed prior to resuming use.

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Additional Information and Safety Notes

Cleaning, disinfection and sterilization of parts in contact with the patient ab-01 The following instructions are subject to change without notice. Always follow the specific procedures that accompanied the parts (e.g., electrodes); your institution's guidelines for cleaning, disinfecting and sterilizing parts; and the instructions from the manufacturer of the sterilizing unit. However, the electrode sterilization temperature must NEVER exceed the value listed on this page, or damage to the electrode may result. ab-02 Natus Neurology Incorporated electrodes To help ensure patient safety, prevent cross infections and provide effective service, Natus Neurology Incorporated electrodes must be properly maintained. Electrode maintenance should include cleaning and sterilizing before each use. ab-03 Cleaning Cleaning is the removal of all foreign material (e.g., soil, organic material) from electrodes. Electrodes should be thoroughly cleaned in soap and water using a soft brush. Proper cleaning must precede sterilization. ab-04 Sterilizing Electrodes can be wet or dry autoclaved. Temperatures should not exceed 140° C (284° F). Minimum recommended cycle time is 10 minutes. See sterilizer manufacturer's instructions for details including duration and loading. ab-05 Electrodes can be ethylene oxide gas (eto) sterilized. Temperatures should not exceed 133° C (271.4 F) unless otherwise noted in the instructions that shipped with the electrodes. Also see sterilizer manufacturer's instructions for details including: sterilization cycle time, aeration, temperature and loading. ab-06 Natus Neurology Incorporated EEG cup, subdermal, nasopharyngeal, and

epidural spinal electrodes cleaning and sterilization instructions The following cleaning and sterilization instructions apply to Natus Neurology Incorporated EEG cup electrodes, subdermal electrodes, nasopharyngeal electrodes and epidural spinal electrodes.

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Natus Neurology Incorporated Cleaning, disinfection and sterilization of parts continued ab-07 1. Prior to sterilization, electrodes should be thoroughly cleaned using an enzymatic detergent specifically formulated for medical devices. Thorough cleaning must be followed by a thorough rinse. ab-08 2. After cleaning, the electrodes may be soaked in a 2% glutaraldehyde preparation or an EPA registered disinfectant with tuberculocidal properties for disinfection. The electrode should then be thoroughly rinsed. ab-09 3. Gas or steam sterilization may be used - do not exceed 140° C (284° F).

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Additional Information and Safety Notes

Safety notes General safety notes The Safety Notes apply to all Nicolet Brand systems that have guided you to this publication unless otherwise noted. Related safety notes have been grouped under various topics. Additional information related to the various safety notes may appear under several topics. Therefore, please read all of the information in this publication. ac-01 This system is not explosion-proof. Do not use in the presence of flammable anesthetics.

ac-02 Improper grounding is a safety hazard. ac-03 The system uses a three-wire power cord with a hospital grade plug (for non-U.S.A. applications, the IEC 60601-1 - approved plug). The chassis is earth-grounded. For grounding reliability, connect the device to a hospital grade or hospital only receptacle (for international applications, the IEC 60601-1 - approved receptacle). ac-04 Inspect the system prior to first startup and frequently prior to usage to examine for and replace damaged components and tighten any loose connections. ac-05 In all cases, the original data must be reviewed by a trained medical professional if a clinical decision is involved. ac-06 Use of this device shall only be in medical use rooms. ac-07 A power interruption during a recording could cause loss of data in the current recording. If you experience frequent power interruptions, Natus Neurology Incorporated recommends you use an Uninterruptable Power Supply (UPS) to help prevent interruptions. ac-08 Radio transmitting equipment, cellular phones, etc. shall not be used in the close proximity of the device since this could influence the performance of the device.

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Natus Neurology Incorporated General safety notes continued ac-09 Be careful using the equipment near short-wave or micro-wave devices. If the equipment is used in an area where there are therapeutic short-wave or micro-wave devices, remember that these may cause instability and interfere with the correct working of the equipment. Do not place the equipment near X-ray or diathermy devices. ac-10 The potential for electrical shock is present if device covers are removed. Refer servicing to qualified personnel. ac-11 For waveform and other specifications, see “Product Specification 169-six digit number” that came with your Natus Brand device. ac-12 Replace damaged parts immediately. Cables, connectors, accessories, or other parts of the equipment must be replaced immediately when damaged or not working correctly. In these cases, contact the nearest authorized servicing center. ac-13 Follow your institution's safety guidelines while installing, servicing, and using the system and any of its components. ac-14 If the system is dropped or otherwise mishandled, check all system functionality and electrical safety test before resuming use. ac-15 Use onlyNatus Neurology Incorporated approved/supplied accessories, software, or components on your system. See your Natus Neurology Incorporated distributor or call 1-800-356-0007 in the USA. Use of non-approved components may adversely affect the functionality of your system.

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Additional Information and Safety Notes General safety notes continued ac-16 Proper use of this device depends on careful reading of all instructions and labels. ac-17 Federal law in the U.S.A. and Canada restricts the sale, distribution or use of this device to, by or on the order of a licensed medical practitioner. ac-18 Use this system only in humidity-controlled, medically used rooms, with an anticipated humidity range of 20-80%. ac-19 Do not attempt any procedures requiring specialized test equipment or access to the interior of the instrument. ac-20 Switch off all power to the system before attempting any service and maintenance. ac-21 The AC power outlets on the iso-power box are intended for use with Nicolet approved components only. Use of any other equipment may result in damage to the power unit. ac-22 Do not tilt a laptop's screen back too far or the screen may be damaged. ac-23 Inspect the power cord often for fraying or other damage. DO NOT operate the apparatus if the power cord or plug is damaged. ac-24 The brakes fitted to the cart castors should be applied whenever the system is left unattended. ac-25 Be sure to lock all wheel castors on your system cart before using the system for patient testing. Locked castors help ensure system ground continuity. ac-26 Ensure the switches to the main system and monitor are OFF and they are unplugged before you begin cabling. ac-27 Do NOT use cables in the presence of unattended and unsupervised children. ac-28 Do NOT wrap cables around your neck.

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Electrical shock (line voltage) The following Warnings are not all inclusive. Please read all of the Safety Notes in this guide for additional shock warnings. ad-01 Failure to follow all guidelines may cause electrical shock. ad-02 Plugging/unplugging power cord in the presence of combustible gas may cause an explosion. ad-03 System components immersed or in contact with fluids may cause electrical shock. ad-04 Use of non-Nicolet Brand device(s) could introduce source currents to the patient, which may cause electrical shock. ad-05 Loss of AC neutral due to damage to the neutral conductor may cause electrical shock. ad-06 Loss of AC ground connection may cause electrical shock. ad-07 Over voltage conditions due to a fault in other equipment may cause electrical shock. ad-08 Over voltage conditions due to application of external voltages to the system may cause electrical shock. ad-09 Over voltage conditions due to the input voltage exceeding the operating range may cause electrical shock. ad-10 Misinstallation of cables on/to the system may cause electrical shock. ad-11 Use of non-Natus Neurology Incorporated supplied or recommended components or accessories may prevent the application of the risk control measures unique to Natus Neurology Incorporated parts from being applied, which may cause electrical shock. ad-12 Damaged power cord contacting ungrounded metal component(s) may cause electrical shock. ad-13 Assembly of computerless systems not per IEC60601-1 may cause electrical shock. ad-14 Source currents to the patient due to use of Natus Neurology Incorporated repaired (with no leakage testing) components may cause electrical shock. ad-15 Improper external headbox connections may produce sourcing of current to the patient, which may cause electrical shock. ad-16 Plugging an electrode into the headbox and allowing the loose ends to make contact with hazardous voltages can cause electrical shock.

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Additional Information and Safety Notes Data misinterpretation, corruption, loss, false positives, false negatives, etc. The following Cautions describe conditions that may inadvertently alter data and are not all inclusive. Please read all of the Safety Notes in this guide for additional cautions and information. ae-01 Adding USB devices while the system is on-line. ae-02 EMI susceptibility to electro-cautery. ae-03 EMI susceptibility to diathermy and defibrillation. ae-04 Swapping the amplifier and stimulator electrodes on the patient. ae-05 Damaged sensor/electrode device. ae-06 Misapplication of system hookup. ae-07 User error resulting in entry of erroneous data. ae-08 User error resulting in incorrect control of the system. ae-09 Misdesignation of ‘normal’ signal by unskilled/untrained user under local or remote control. ae-10 Data transfer error. ae-11 User error in understanding the data manipulation processes. ae-12 Loss of system power. ae-13 Corruption/loss of data over network due to unplugging the network cable or data interruption during data transfer/hardware failure/ corrupt software. ae-14 Unintended remote control network access to the acquisition system or amplifier. ae-15 Inadequate network bandwidth.

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Natus Neurology Incorporated Data misinterpretation, corruption, loss, false positives, false negatives, etc. continued. ae-16 Lack of indication of seizure due to incorrect setting of detection parameters or insufficient data collected prior to seizure event. ae-17 Failure of video capture hardware/software. ae-18 Corruption of data due to external stimulus applied to the patient (e.g., magnetic stimulation, electrical stimulation or defibrillation, etc.) ae-19 Data corrupted by frequencies aliased to the data sample rate. ae-20 User or service error when creating mapper file for patient information imported from the medical center. ae-21 Inaccurate SpO2 reading after amplifier has been in for service or as a result of improper maintenance. ae-22 Inaccurate SpO2 reading due to using non-Nonin probes or incorrect Nonin probes. ae-23 Patient manipulation of electrode connections or amplifier settings out of supervision by technologist. ae-24 System dropped or mechanical damage.

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Additional Information and Safety Notes Physical injury af-01 Warnings in this guide describe conditions that may cause personal

injury to the patient and are not all inclusive. Please read all of this guide for additional cautions and information.

Amplifier arm ag-01 Take care when removing the amplifier arm tie wrap. The amplifier arm is spring-loaded and may snap open possibly causing injury.

ag-02 When using the amplifier arm, take care not to swing it into the monitor screen. The screen is fragile and may break.

Electrodes and transducers ah-01 Connect patient electrodes to fully electrically-isolated physiological devices only. Connection to any other devices or external electrical outlets may result in personal injury. For patient safety, do not place the metal connectors on the electrode lead wires on a metal surface or any connection to earth ground. ah-02 Take care when using the equipment simultaneously with other instruments. In the event the patient is connected to several instruments at the same time, it is necessary to remember that the sum of the dispersion currents determined by each instrument may endanger the patient’s life. ah-03 Simultaneous connection of a patient to high frequency surgical equipment and the Nicolet Brand system may result in burns at the electrode site and damage the Nicolet Brand system. ah-04 Use only electrodes of adequate size and properly applied by qualified medical personnel to avoid patient skin reactions or burns.

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Natus Neurology Incorporated Electrodes and transducers continued. ah-05 Using electrodes with current densities greater than 2 mA r.m.s./cm2 may require the special attention of the operator. ah-06 Electrodes of inadequate size or unsuitable application could provoke skin reactions or burns. Natus Neurology Incorporated recommends the use of disposable, pre-gelled, silver/silver chloride electrodes with a contact area of 20 mm diameter or larger. These electrodes contain an adhesive that maintains the electrode skin position and contact during electrical stimulation and are designed for use of the maximum output of the electrical stimulator. ah-07 Avoid contact of patient and electrodes with conductive metal items. When the equipment is connected to other instruments supplied by the mains, the entire input circuit to which the patient is connected is electrically isolated (floating isolation). It is necessary to avoid the patient and any conductive part connected to the patient (electrodes, connectors, and transducers) from coming into contact with conductive parts (ground included). Please observe this precaution to avoid compromising the equipment isolation level. This precaution must be observed in order to avoid accessible metal parts of the device from coming into contact with external conductive parts that could result in damaging the isolation level of the equipment. ah-08 Although patient connections are electrically isolated, these connections are not intended for direct cardiac contact. ah-09 Do not allow conductive parts of electrodes and connectors to contact conductive parts or ground. ah-10 Do NOT touch pins of detached connectors of any kind. ah-11 The electrode and sensor through which the signal is captured from the body of the patient are not part of the amplifier system. It is MANDATORY to use only electrodes or sensors cleared or approved for commercial use by FDA (USA) or CE marked. ah-12 Never touch the patient while connecting or disconnecting any connectors. ah-13 Use only Natus Neurology Incorporated approved/supplied electrodes and transducers. See your Natus Neurology Incorporated distributor or call 1-800-356-0007 in the USA. Use of nonapproved electrodes or transducers might adversely affect the function of your system

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Additional Information and Safety Notes Electrical stimulators for Nicolet EDX, Nicolet Endeavor, Nicolet VikingSelect, Nicolet VikingQuest, Synergy Focus and Synergy Plinth and PIU ai-01 The stimulator probe can deliver electrical output of up to 400 V or 100 mA. This device is intended for use only by or on the order of a licensed medical practitioner. ai-02 During direct nerve stimulation (i.e., stimulation of an exposed nerve or nerve root), the stimulator duration should be limited to 100 s or shorter and the stimulator output level should not exceed 2.5 mA or 10 V. ai-03 It is necessary to be careful when using the equipment in the case of patients with implanted electric devices, especially heart pace-makers, because the equipment may cause the cardiac stimulator malfunctions. Patients with cardiac pacemakers should not undergo any examination with this equipment without authorization and under the direct control of a specialized physician. ai-04 Particular precaution must be considered during use of strong emission sources such as High Frequency surgical equipment and similar so that, for example, the HF-cables are not routed on or near the device. If in doubt, contact a qualified technician or your local representative. ai-05 For initial electrical stimulation, set the electrical intensity (current or voltage) at a low level. Slowly increase the intensity to the desired level of stimulation to prevent patient discomfort. ai-06 If you disconnect the electrical stimulator from the system with the system power on, an unwanted stimulation of the patient could result. ai-07 Do not attempt to connect stimulating electrodes directly to the stimulator probe with the probe head removed. You may damage the stimulator probe. ai-08 Prevent electrode paste from getting into the eye, this could cause eye irritation or possible damage. ai-09 Improper application of electrodes may prevent or interfere with data acquisition. ai-10 Make sure that the recording electrodes are connected to the amplifier head box and not the electrical stimulator. This could result in unwanted stimulation through the recording electrodes. ai-11 The output waveform of the Electrical stimulator is AC coupled through a transformer. Therefore, there is no DC component. The pulse durations can range from 10uS to 1000uS, the repetition frequencies range from 0.1Hz to 200Hz. ai-12 The maximum amplitude, in the constant voltage mode, is 400V. The maximum amplitude, in the constant current mode, is 100mA. Both of these maximums are with respect to a 4Kohm load. As the load impedance is increased, the current will drop off according to the equation  I = 400V/R. As the load impedance is decreased below 3.2Kohm, the voltage will drop off according to the equation V = 125mA x R. ai-13 The maximum energy output of the electrical stimulator into a 1Kohm load is  (180mA)2 x 1Kohm x 1mS = 32.4mJ.

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