VIASYS Nicolet and NicoletOne System Additional Info and Warnings Rev 06

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VIASYS NeuroCare

Additional Information and Safety Notes U.S. Patents... 3 European Authorized Representative... 3 Compliance... 3 Service manuals for your system... 4 Specifications VIASYS NeuroCare systems... 4 Preventive maintenance... 5 Cleaning, disinfection and sterilization of parts in contact with the patient... 6 Pulse width... 7 Safety notes... 8 General safety notes... 8 Amplifier arm ...10 Electrodes and transducers ...11 Stimulators / Stimulation ...13 Bovie / Electrocautery ...14 Implant electrodes ...15 EMG ...15 Leakage current ...15 Batteries ...15 Recycling / disposal...16 Defibrillation ...16 Mains operated equipment with additional power supply ...16 Replacement of fuses and other parts ...17 Hard drive ...17 Restricted environmental conditions for operation, transport and storage. ...18 Electrodes and Amplifiers ...19 Isolation / Isolation transformer ...20 Software ...21 Electromagnetic Compatibility (EMC) Information ...22 ESD handling ...23 Networking ...24 Operating environment ...25 System connections ...26

This publication contains information applicable to the following VIASYS NeuroCare products: • Nicolet Endeavor • Nicolet Endeavor CR • NicoletOne cEEG • NicoletOne nEEG & LTM • NicoletOne Monitor • Nicolet vEEG • VikingQuest • VikingSelect • Nicolet 2015 Visual Stimulator • NicoletOne Ambulatory EEG • NONIN Pulse Oximeter

Continued on the next page.

Tel: 608/441-2000 Toll free: 1-800-356-0007 Fax: 608/441-2004

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Global Cautions and Warnings applicable to the above products are combined in the first section of this publication. Specific VIASYS NeuroCare products Cautions and Warnings are located towards the end of this publication. Please read this publication entirely before applying power to your VIASYS NeuroCare system. Information in this publication may be changed without notice. VIASYS NeuroCare 5225 Building 2 Verona Road Madison, Wisconsin USA 53711-4495

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VIASYS NeuroCare Product Specific Cautions and Warnings ...28 NicoletOne cEEG, NicoletOne nEEG / LTM, NicoletOne Monitor, and Nicolet vEEG: ...28 NicoletOne cEEG, NicoletOne nEEG / LTM, NicoletOne Monitor, and Nicolet vEEG continued: ...29 NicoletOne cEEG, NicoletOne nEEG / LTM, NicoletOne Monitor, and Nicolet vEEG continued: ...30 Nicolet Endeavor and Nicolet Endeavor CR: ...31 VikingQuest: ...32 VikingSelect: ...33 NicoletOne Ambulatory EEG ...34 Nicolet 2015 Visual Stimulator ...35 NONIN Pulse Oximeters ...36 Typical international symbols...40 Typical symbols on VIASYS NeuroCare systems...48 Typical VIASYS NeuroCare labels...50 Typical VIASYS NeuroCare voltage labels...53

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Additional Information and Safety Notes

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

European Authorized Representative The European Authorized Representative for this product is: VIASYS Healthcare Welton Road Warwick, CV34 5PZ United Kingdom

Compliance The CE0344 and CE93/42/EEC marks identify compliance with Medical Device Directive 93/42/EEC.

Copyright 2005 VIASYS Healthcare - VIASYS NeuroCare

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VIASYS NeuroCare

Service manuals for your system A Service manual which contains servicing information that VIASYS NeuroCare 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. VIASYS Healthcare Inc. VIASYS NeuroCare 5225-2 Verona Road Madison, Wisconsin USA 53711-4495 Tel: 608/441-2000 Toll free: 1-800-356-0007 Fax: 608/441-2004 E-mail: [email protected] World Wide Web: www:viasyshealthcare.com

Specifications VIASYS NeuroCare systems Specifications are available from VIASYS NeuroCare for your system.

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Additional Information and Safety Notes

Preventive maintenance 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. 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. 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. 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. It is recommended that all repairs be performed by a qualified VIASYS NeuroCare service representative only. You have the sole responsibility for any malfunctions resulting from improper maintenance or repair by anyone other than an authorized VIASYS NeuroCare representative. 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 VIASYS NeuroCare Inc. published specifications. It is recommended that all repairs be performed by a qualified service representative only. See the following Safety Summaries in this publication for additional safety considerations. Switch off all power to the system before attempting any service, maintenance, or preventive maintenance. 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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VIASYS NeuroCare

Cleaning, disinfection and sterilization of parts in contact with the patient 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.

VIASYS NeuroCare electrodes To help ensure patient safety, prevent cross infections and provide effect service, VIASYS NeuroCare electrodes must be properly maintained. Electrode maintenance should include cleaning and sterilizing before each use.

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.

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. Electrodes can be ethylene oxide gas (eto) sterilized. Temperatures should not exceed 133° C 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.

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Additional Information and Safety Notes Cleaning, disinfection and sterilization of parts continued VIASYS NeuroCare EEG cup, subdermal, nasopharyngeal, and epidural spinal electrodes cleaning and sterilization instructions The following cleaning and sterilization instructions apply to VIASYS NeuroCare EEG cup electrodes, subdermal electrodes, nasopharyngeal electrodes and epidural spinal electrodes. 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. 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. 3. Gas or steam sterilization may be used - do not exceed 140° C (284° F).

Pulse width The term pulse width is the length of time from when the pulse starts (a) and when the maximum pulse ends (b) as shown below.

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VIASYS NeuroCare

Safety notes General safety notes The Safety Notes apply to all VIASYS NeuroCare 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. This system is not explosion-proof. Do not use in the presence of flammable anesthetics. Improper grounding is a safety hazard. 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). Inspect the system prior to first startup and frequently prior to usage to examine for and replace damaged components and tighten any loose connections. In all cases, the original data must be reviewed by a trained medical professional if a clinical decision is involved. Use of this device shall only be in medical use rooms. A power interruption during a recording could cause loss of data in the current recording. If you experience frequent power interruptions, VIASYS NeuroCare recommends you use an Uninterruptable Power Supply (UPS) to help prevent interruptions. 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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Additional Information and Safety Notes General safety notes continued 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. The potential for electrical shock is present if device covers are removed. Refer servicing to qualified personnel. For waveform and other specifications, see “Product Specification 169-xxxxxx” that came with your VIASYS NeuroCare device. 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. Follow your institution's safety guidelines while installing, servicing, and using the system and any of its components. If the system is dropped or otherwise mishandled, check all system functionality and electrical safety test before resuming use. Use only VIASYS NeuroCare approved/supplied accessories, software, or components on your system. See your VIASYS NeuroCare 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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VIASYS NeuroCare

General safety notes continued Proper use of this device depends on careful reading of all instructions and labels. 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. Use this system only in humidity-controlled, medically used rooms, with an anticipated humidity range of 20-80%. Do not attempt any procedures requiring specialized test equipment or access to the interior of the instrument. Switch off all power to the system before attempting any service and maintenance. 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. Do not tilt a laptop's screen back too far or the screen may be damaged. Inspect the power cord often for fraying or other damage. DO NOT operate the apparatus if the power cord or plug is damaged. The brakes fitted to the cart castors should be applied whenever the system is left unattended. 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. Ensure the switches to the main system and monitor are OFF and they are unplugged before you begin cabling.

Amplifier arm Take care when removing the amplifier arm tie wrap. The amplifier arm is spring-loaded and may snap open possibly causing injury. When using the amplifier arm, take care not to swing it into the monitor screen. The screen is fragile and may break.

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Electrodes and transducers 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. 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. Simultaneous connection of a patient to high frequency surgical equipment and the VIASYS NeuroCare system may result in burns at the electrode site and damage the VIASYS NeuroCare system. Use only electrodes of adequate size and properly applied by qualified medical personnel to avoid patient skin reactions or burns. Using electrodes with current densities greater than 2 mA r.m.s./cm2 may require the special attention of the operator. Electrodes of inadequate size or unsuitable application could provoke skin reactions or burns. VIASYS NeuroCare 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. 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. Although patient connections are electrically isolated, these connections are not intended for direct cardiac contact. Do not allow conductive parts of electrodes and connectors to contact conductive parts or ground. Do NOT touch pins of detached connectors of any kind.

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VIASYS NeuroCare

Electrodes and transducers continued 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 approved for commercial use by FDA (USA) or CE marked (93/42EEC directive). Never touch the patient while connecting or disconnecting any connectors. Use only VIASYS NeuroCare approved/supplied electrodes and transducers. See your VIASYS NeuroCare distributor or call 1-800-356-0007 in the USA. Use of non-approved electrodes or transducers might adversely affect the function of your system.

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Stimulators / Stimulation 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. During direct nerve stimulation (i.e., stimulation of an exposed nerve or nerve root), the stimulator duration should be limited to 100 ms or shorter and the stimulator output level should not exceed 2.5 mA or 10 V. 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. 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. 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. Use of improper auditory transducer or setting high stimulation levels could cause excess stimulation and hearing damage. If you disconnect the electrical stimulator from the system with the system power on, an unwanted stimulation of the patient could result. Do not attempt to connect stimulating electrodes directly to the stimulator probe with the probe head removed. You may damage the stimulator probe. Prevent electrode pasted from getting into the eye, this could cause eye irritation or possible damage. Improper application of electrodes may prevent or interfere with data acquisition. 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. Use of high level or prolonged sound pressure levels may cause permanent hearing loss.

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Bovie / Electrocautery 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. Always use appropriate Bovie (high frequency surgical equipment) protection devices with amplifiers for connecting all recording electrodes. Use the largest surface area electrode possible for the patient ground electrode. Avoid prolonged activation of the Electrosurgery Unit (ESU). Avoid ESU activation in close proximity of the monitoring electrodes. Read and follow all safety guidelines for operating room systems. Always use an O.R. headbox for connecting electrodes when electrocautery devices are used. Always use appropriate electrocautery protection devices for connecting all recording electrodes to amplifier(s). Do not apply metal or electrodes to a patient being treated with Diathermy therapy. Burns and/ or shock may occur at the site of any metal-to-patient contact. When the system is used simultaneously with high frequency surgical equipment, burns may occur at the recording or stimulating electrode site. Take care when using the equipment at the same time with other radio frequency instruments. In the event the equipment is used in a surgery room at the same time with a radio knife (Radio-Frequency instrument = RF), it is necessary to hold the radio knife point as far as possible from the electrodes, in order to reduce the risk of RF currents effect on the electrodes and consequent burns to the patient. Therefore, it is necessary to use electrodes with a larger surface contact with the patient’s body, in order to limit the RF current density to acceptable values. If it is not possible to use the proper electrodes, disconnect the patient from the equipment before using radio-frequency instruments. While running high frequency surgical units, the recording of data may not be possible while the surgical unit is active. Do not place the equipment near X-ray or diathermy devices.

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Additional Information and Safety Notes

Implant electrodes Advise patients with implanted electronic devices not to be subjected to electrical stimulation unless specialist medical opinions have first been obtained.

EMG 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 guard against patient discomfort. For safety and efficiency during electrical stimulation, the cathode and anode spacing should not exceed 4.0 cm. During direct nerve stimulation (stimulation of an exposed nerve or nerve root), the stimulator duration should be limited to 100 µsec. or shorter and stimulator output level should not exceed 2.5 mA or 10 V. Prior to each case, check stimulation functionality. If ever in doubt, always reverify the functionality of the stimulators.

Leakage current This instrument is designed to comply with the European standard for medical electronic equipment IEC/EN 60601-1, which lays down the permissible levels of leakage current from individual products. A potential hazard exists in the summation of leakage currents caused by connecting multiple pieces of equipment together. Because this instrument can be used in conjunction with standard electronic devices, the total leakage current should be tested at regular intervals.

Batteries Where applicable, instructions for those systems using batteries as the primary power source are located in the main User's guide. Additional information from the manufacturer concerning the battery (battery charger) may also have accompanied your system. Do not dispose of batteries by incineration.

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VIASYS NeuroCare

Recycling / disposal Many local laws and regulations consider electric equipment-related waste as hazardous or requiring special procedures to recycle or dispose of. This includes batteries, printed circuit boards, electronic components, wiring and other elements of electronic devices. Follow all of your respective local laws and regulations for the proper disposal of batteries and any other parts of your system, such as monitors, amplifiers, keyboards, electrodes, etc.D-9 Check the VIASYS websit for recommended instructions and addresses for proper return or disposal of electronic wastes relating to VIASYS Heathcare products in Europe and other localities. The contact information for the WEEE - In Europe VIASYS Healthcare GmbH Neurocare group D-97204 Hoechberg Germany Tel: +49 (0) 931-4972-309 Fax: +49 (0) 931-4972-318

Defibrillation This system is not protected against defibrillation. Remove the patient connections to the system prior to defibrillation. If defibrillation is applied to the patient while still connected to this system, you may damage the system. Always test system operation and leakage current after defibrillating your patient.

Mains operated equipment with additional power supply If there is any doubt about the external Protective Earth Conductor arrangement's integrity for Class I Equipment connected to a Supply Mains and alternatively used with an Internal Electrical Power Source, the equipment should be operated from its Internal Electrical Power Source. Serious injury or damage to the system may result otherwise. For mains operated systems using an additional power source which is not automatically maintained in a fully usable condition, periodic testing or replacement of the additional power source is recommended.

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Additional Information and Safety Notes

Replacement of fuses and other parts Instructions for changing fuses for the Isolation Transformer (if applicable for your system) is located in the installation instructions, which shipped with your system. This document will typically be labelled as Users Guide or, in some instances, Read Me First or Utilities Guide. Likewise, instructions for connecting interchangeable and/or detachable parts to your system is located in the installation instructions, which shipped with your system.

Hard drive Do not attempt to reformat the hard drive without consulting a qualified VIASYS NeuroCare Service Representative first. Initializing and reformatting the hard disk erases all data previously stored on the system. Follow the steps listed in the VIASYS NeuroCare’s documentation or only under the direction of a qualified Service Representative.

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VIASYS NeuroCare

Restricted environmental conditions for operation, transport and storage The following general information (subject to change without notice) is applicable to your system unless otherwise noted.

Operating (in use) The following information is applicable to all systems in this publication unless otherwise noted in the specific system’s User guide. •Temperature: 60 to 90° F, (15.6 to 32.2° C). •Relative Humidity: 20-80%, noncondensing. •Altitude: 0-10,000 ft, (0-3 km).

Nonoperating (in storage) The following information is applicable to all systems in this publication unless otherwise noted in the specific system’s User guide. •Temperature: 0 to 132° F, (-17.7 to 55° C). •Relative Humidity: 10% - 90%, noncondensing. •Altitude: 0-40,000 ft, (0-12 km).

Shipping conditions Normal instrument shipping conditions may exceed recommended storage and operating specifications. Original instrument packaging has been designed to allow shipment and storage in typical shipping conditions for up to 60 days. Typical shipping conditions may range in temperature from -34° C to 65° C, and humidity levels may vary from 15% - 95%, noncondensing.

Protective packaging measures This equipment is designed for normal medical use. For storage and transportation, additional protection from environmental conditions and handling is recommended. Protect from condensation and impact.

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Additional Information and Safety Notes

Electrodes and Amplifiers Do not measure the impedance of indwelling grid electrodes or needle electrodes with the needle positioned in the patient. This practice may result in patient injury. Do not measure the impedance of electrodes in contact with your patientís cornea. This practice may result in patient injury Using electrodes with current densities greater than 2 mA r.m.s./cm2 may require the special attention of the operator. Electrode application materials can cause eye irritation. Avoid contact with the eyes. To reduce the risk of injury, disconnect all recording and stimulating electrodes from the system before you turn the system power off and on. Connect all patient electrodes to fully electrically-isolated physiological devices only. Connection to any other devices or external electrical outlets may result in personal injury. Do not stimulate a patient with an implanted electronic device, such as a cardiac pacemaker, without the approval of a licensed medical practitioner. Do not operate the stimulator in close proximity (i.e., less than 1 meter) to a shortwave or microwave therapy device. This practice may lead to unstable electrical stimulus output, which may cause patient burns. Electrodes of inadequate size or unsuitable application could provoke skin reactions or burns. VIASYS NeuroCare recommends the use of disposable, pre-gelled silver/silver chloride electrodes with a contact area of 20 mm in diameter or greater. These electrodes contain an adhesive that maintains the electrode skin position/contact during electrical stimulation. Always use the largest surface electrodes possible for the patient ground electrode. Advise patients with implanted electronic devices not to be subjected to electrical stimulation, unless specialist medical opinions have first been obtained. Do not set the amplifier on the operating room floor or any other floor on which the amplifier may come in contact with any kind of fluids.

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