Hardware Instructions for Use
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FOCUS
Hardware Instructions for Use
Focus Instructions for Use
© 2013, Alpine Biomed ApS. All rights reserved. The contents of this manual are the property of Alpine Biomed ApS. Any reproduction in whole or in part is strictly prohibited. At the time of printing / transferring to the CD-ROM/DVD, this manual correctly described the device and its functions. However, as modifications may have been carried out since the production of this manual, the system package may contain one or more addenda to the manual. This manual including any such addenda must be thoroughly read before using the system. The following situation voids any guarantee(s) and obligations for Alpine Biomed ApS: -The device is not used according to the enclosed manuals and other accompanying documentation. This system is CE marked in conformity with the requirements in the Medical Device Directive 93/42/EEC. Alpine Biomed, ApS is a division of Natus Medical Incorporated. Alpine Biomed and Keypoint are registered trademarks of Alpine Biomed in the U.S. and in other countries.
This manual is intended to be used in conjunction with the Leadpoint Instructions for Use for the Leadpoint program. Before starting a test, make sure you read the instructions for use and fully understand how to operate the system. Pay special attention to all Warnings and Cautions in this manual and in any other documentation accompanying the equipment. For any further questions regarding the operation of this device, please contact your customer support representative.
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Focus Instructions for Use
Contents Focus with Leadpoint Software ... 4 Intended Use ... 4 Safety Information ... 4 Safety Requirements... 6 Excerpt from the IEC 60601-1 (IEC 60601-1-1) Standard ... 8 Maintenance ... 9 Decontamination ... 9 Cleaning Instructions ... 9 Preventative Maintenance ... 9 Waste Management ... 10 Classification ... 11 System Overview ... 12 Focus Main Unit ... 12 System Setups... 13 Main Unit... 15 Technical Specifications ... 16 Control Panel ... 17 Amplifier... 22 MER Amplifier ― 5 Channels ... 22 Stimulator... 24 Safety Information ... 24 Stimulator Overload ... 24 Macro Stimulator ... 25 Power Up Test... 27 Messages ... 27 PC Requirements ... 28 Safety... 28 Performance ... 28 General Regulatory Symbols ... 29
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Focus Instructions for Use
Focus with Leadpoint Software Intended Use The Leadpoint microelectrode targeting system is intended to assist in neurosurgical procedures where recording of neuronal activity and stimulation of brain neurons will aid in the placement of depth electrodes. The Leadpoint microelectrode targeting system is intended to be used in the operating room by a neurosurgeon, neurologist, or clinical neurophysiologist.
Safety Information Danger Possible explosion hazard, if used in the presence of flammable anesthetics.
Warnings Do not use this PC-based equipment for anything else other than what it is intended for by the manufacturer −i.e. carrying out tests on patients and possibly subsequent report generation. Do not install any other software than the Leadpoint Software. Alpine Biomed ApS assumes no responsibility when the equipment is not used as described in this manual. The device is not MRI compatible. The device is not intended for direct cardiac application. The device is not suitable for intensive care monitoring use. Any interruption of the protective earth conductor inside or outside of the device, or disconnection of the protective earth connector is likely to make the device dangerous. Intentional interruption is prohibited. The protective earth (ground) conductor should be checked regularly. Due to risk of electric shock, the operator and / or patient must not directly or indirectly touch the metal shield on the LINK cable attached to the rear of the amplifier. Do not connect the "patient ground" to the protective/functional earth connection on the rear panel of the Isolating Transformer; rear panel of the Main Unit; or to any other "ground" connections, as the electrode inputs are galvanically isolated.
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Focus Instructions for Use
Simultaneous connection of a patient to HF surgical equipment may result in burns at the site of the electrical stimulation or recording electrodes, and possible damage to the electrical stimulator or the electrode input amplifiers. Operation in close proximity (e.g. 1m) to short wave or microwave therapy equipment may produce instability in the electrical stimulator output. Electrical equipment for medical use requires special EMC precautions and needs to be installed and serviced according to the EMC documentation of device. When connecting the integrated LAN port to a network system, the NetBox Ref. 9031G046x must be properly connected into the LAN line between the LAN port and the network system. Do not make a direct connection between the PC LAN Port and the Network System! The NetBox Ref. 9031G046x provides electrical insulation to prevent dangerous electrical current from reaching the patient in the event that the network system becomes accidentally electrically shorted to a high voltage line. Failure to properly install the NetBox Ref. 9031G046x when making the LAN connection annuls this product’s compliance certification with the IEC 60601-1 (IEC 60601-1-1) international safety standards for medical electrical equipment. The use of accessories, electrodes, and cables other than those specified by Alpine Biomed may result in increased emissions, or decreased immunity of the equipment. Use only optional devices specified by Alpine Biomed ApS in order to comply with IEC 60601-1 (IEC 60601-1-1). When connecting other equipment, attention must be paid to standard: IEC 60601-1 (IEC 60601-1-1) Medical Electrical Equipment, (Part 1…). Failure to comply with this standard may result in safety risk. The equipment should not be used adjacent, or stacked with other equipment. 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. Dangerous physiological effects! The current stimulator may give off dangerous currents and voltage. When operating the current stimulators, be careful not to expose patients to high currents. Before connecting or disconnecting the stimulation electrode, always “reset” the stimulator. Pay attention to the stimulator intensity indicator during the use of the program. –See the section Stimulator Overload in this manual.
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Focus Instructions for Use
Electrostatic Sensitive Amplifier Input connectors – Do not touch the Amplifier Input connectors as it may damage the amplifier, or affect its performance.
Cautions Always use shielded power line cables from Alpine Biomed to avoid hum line interference, especially near the patient, or the amplifier. Portable and mobile RF communication equipment can affect electrical equipment for medical use. Electric shock hazard. Do not remove the cover. Refer servicing to qualified service personnel. Avoid accidental contact between connected, but unapplied electrodes and other conductive parts – including those connected to protective earth. Avoid electrical stimulation for a prolonged period. Do not use cleaning detergents, or cleaning agents based on solvent, silicon-based, abrasive and/or flammable substances to clean the equipment.
Safety Requirements CAUTION This device is intended to be used by qualified medical personnel, knowledgeable in the field of neurophysiology and neurophysiological assessment, as well as in the use of the product /Focus system. This device has been designed and tested in accordance with IEC 60601-1 Medical Electrical Equipment, cf. the text on IEC 60601-1 (IEC 60601-1-1) further below in this section. The device has been designed for indoor use at temperatures between +10°C and +35°C (+50°F to +95°F). The mains plug must only be inserted in a mains socket outlet provided with a protective earth contact. It is forbidden to use extension cords. It is forbidden to use multiple portable socket outlets (MPSO).
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Focus Instructions for Use
WARNING Any interruption of the protective earth conductor inside or outside of the device or disconnection of the protective/functional earth connector is likely to make the device dangerous. Intentional interruption is prohibited. The protective earth / ground conductor should be checked regularly.
Adhere to the following recommendations for safe operation of the device: When connecting medical equipment being supplied from an outlet located in a non-medically used room, or when connecting non-medical electrical equipment to this device, pay attention to the requirements of IEC 60601-1 (IEC 60601-1-1), Safety Requirements for medical electrical systems, cf. the text on IEC 60601-1 (IEC 60601-1-1), further below in this section. When the device is connected to its mains supply, connectors may be live, and any opening of covers or removal of parts possible only with the aid of a tool is likely to expose live parts. The device must be disconnected from all voltage sources before being opened for any adjustment, replacement, maintenance or repair. Service must be referred to Alpine Biomed ApS authorized service personnel, except for such works described in this manual as being performed by the operator. Make sure that only fuses with the required rated current and of the specified type are used for replacement. The use of makeshift fuses and the shortcircuiting of fuse holders are prohibited. Where more than one piece of equipment is connected to the patient, attention must be paid to the summation of patient leakage currents. Whenever it is likely that the protection has been impaired, the device shall be made inoperative and be secured against any unintended operation. Call qualified service personnel to conduct at least a functional test and a safety check that should include the following: -Insulation test; -Ground continuity test; and -Leakage current test, according to IEC 60601-1. The protection is likely to be impaired if, for example, the device: -Shows visible damage; -Fails to perform the intended function(s); -Has been subject to severe transport stresses.
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Focus Instructions for Use
Excerpt from the IEC 60601-1 (IEC 60601-1-1) Standard WARNING When connecting other equipment, qualified attention must be paid to the following excerpt from the medical safety standard to which this system complies.
IEC 60601-1-1 Medical Electrical Equipment, Part 1: General Requirements for Safety. 1. Collateral Standard Safety Requirements for Medical Electrical Systems. IEC 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance. Chapter 16: Medical Electrical Systems.
When connecting to a medical appliance with an F-type applied part, or some additional equipment complying not with IEC 60601-1 but with the relevant safety standard for such equipment, the additional equipment: 1) must either be placed outside the patient environment --the patient environment is any area in which intentional, or unintentional contact can occur between patient and parts of the system (e.g. a printer, VEP Monitor) or as a result of some other person touching parts of the system; ―or― 2) if placed within the patient environment, must be: a) provided with an additional protective earth connector; or b) supplied from a separating transformer, limiting the enclosure/touch leakage current to a value not exceeding: Normal Condition: 0.1 mA or Single Fault Condition 0.5 mA. Please refer to IEC 60601-1 (IEC 60601-1-1) for further details.
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Focus Instructions for Use
Maintenance Decontamination Decontamination that can be performed by the operator is limited to cleaning and disinfecting the device. Any maintenance inside the device must be performed by qualified service personnel only.
Cleaning Instructions Regular cleaning maintenance should be performed according to frequency of use of the device. Always observe your local hygiene authority’s guidelines, and the following points below:
Disconnect the mains power before cleaning the equipment. Clean the equipment surfaces with a clean, slightly damp cloth with a mild detergent (e.g., Wet Wipes®), and wipe it dry. Make sure that no liquids enter the device at push buttons and other openings in the enclosure. CAUTION Do not use cleaning detergents, or cleaning agents based on solvent, silicon-based, abrasive and/or flammable substances.
Disinfection Procedure When disinfecting the equipment, if required, surgical spirit (70%), a Chlorine (1000ppm), or ethanol (70%) detergent may be used. Carefully follow the disinfectant manufacturer’s instructions for use, and the steps under the Cleaning Instructions section above.
Preventative Maintenance Safety Checks The following safety checks should be conducted by qualified personnel only at least once a year and in the event of repair: 1. Inspection for visible damage to device. 2. Inspection of mains cord and connecting cables. 3. Check of electrode cables and patient connections. 4. Check of current stimulator output in all ranges –Ref. KPTest4 Manual. 5. Measurement of insulation resistance. 6. Measurement of leakage currents. 7. Measurement of resistance of protective earth conductor. 8. Measurement of resistance of protectively earthed enclosure and cart parts. 9. Check of Amplifier gain –Ref. KPTest4 Manual.
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Focus Instructions for Use
Waste Management WEEE - Waste Electrical and Electronic Equipment Compliance Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to the local regulations.
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Focus Instructions for Use
Classification Type of protection against electric shock: class I: Equipment in which protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in that means are provided for the connection of the equipment to the protective earth conductor in the fixed wiring of the installation in such a way that accessible metal parts cannot become live in the event of a failure of the basic insulation. Degree of protection against electric shock: Type BF: applied part providing a particular degree of protection against electric shock, particularly regarding: -Allowable leakage current -The applied part is electrically isolated (floating). -Not intended for direct cardiac application. Degree of protection against harmful ingress of water: IP20: ordinary equipment (enclosed equipment without protection against ingress of water). Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of such a mixture. Mode of operation: Continuous operation. Degree of patient vicinity: Whole equipment (system) is suitable for use in the patient environment. Method(s) of sterilization, or disinfecting recommended by the manufacturer: Please, see section on “Maintenance”.
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Focus Instructions for Use
System Overview Focus Main Unit
(1) Main Unit
(2) Notebook PC
(3) Rear Panel
(4) Side Panel
(5) Control Panel
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Focus Instructions for Use
System Setups Focus Notebook Configuration
Focus Standard PC Configuration
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Focus Instructions for Use
Cable Connections Before operating the device, the system parts need to be connected. Follow the steps 1-3 below. 1. Connect all the signal interface cables (USB / HS-Link) as depicted in the illustrations. 2. Connect all the power interface cables as depicted in the illustrations, except the power cord. 3. Connect the power cord to the wall outlet. WARNING Use only optional devices specified by Alpine Biomed in order to comply with IEC 60601-1 (IEC 60601-1-1).
CAUTION Always use shielded power line cables from Alpine Biomed to avoid hum line interference, especially near the patient, or the amplifier.
NOTES Make sure the device connected to the wall power outlet is positioned in such a way to allow easy disconnection from the mains, if needed. Unplugging the power line cable from the mains input on the Main Unit, disconnects the mains power of the complete system.
Digital Encoder (optional) If a digital encoder is used, make sure to follow the installation instructions specified by the manufacturer. Refer also to the “Excerpt from the IEC 60601-1 (IEC 60601-1-1) Standard” in this manual. Once installed, you will need to select the COM Port used by the digital encoder. Open the Leadpoint program, from the Home page, click the Options button, and then click System. NOTE The digital encoder device needs to be connected to the Focus system before starting the Leadpoint program. ―Make sure that the digital encoder cable remains connected until you exit the application.
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Focus Instructions for Use
Main Unit Connection ― Side Panel
CC Stimulator Output (isolated) The CC stimulator output connectors are electronically isolated. CC Stimulator Output Socket (isolated) Support for the Macro Stimulator.
LINK
HS Link Output Connector － MER Amplifier Connection
AEP
AEP Headset Connector
VEP
VEP Goggles Connector
Rear Panel
Protective Earth
Functional Earth To be used for suppression of noise.
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Focus Instructions for Use
Dual USB Connectors – Type A Limited power available. Only used for memory stick and license dongle.
USB Connector – Type B For computer interface.
Footswitch Connector
Input / Output Connector Input / Output Magnetic Stimulation/tendon hammer, or synchronization of external trigger, or external stimulation acquisition.
VEP
VEP Monitor Connector Power Outlet (only for Notebook PC when not used with the Isolating Transformer) Output: Mains 100 - 240VA Max.200VA
Power Inlet Input: 100-240Vac, 50/60Hz, Max. 300VA Fuses F1, F2 : T4A/250V
Technical Specifications For technical specifications, refer to Focus Technical Data Sheet.
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Focus Instructions for Use
Control Panel
Pic
(1) Stimulation Intensity Control Knob
(2) Stimulation Duration Arrow Keys
(3) Stimulation Repetition Rate Arrow Keys
(4) Trace/Marker and Trigger Arrow Keys
(5) Cursor Mode Indicator
(6) Volume/Cursor Control Knob
(7) Volume Indicator
(8) Loudspeaker Mute Indicator
(9) Loudspeaker Mute Key
(10) Software Navigation Keys
(11) Numeric Keypad
(12) Standby Indicator
(13) Power ON Indicator
(14) Software Function Keys
(15) Sweep Speed/Sensitivity Level Arrow Keys
(16) Repetitive Stimulation Key
(17) Stimulation Indicator
(18) Single Stimulation Key
(19) Reset Stimulation Intensity key
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Focus Instructions for Use
Control Functions Power On / Stand By Indicators Power On Stand By
Software Navigation / Software Functions
Software Navigation Keys – Color Coded The Software Navigation keys allow you to navigate through the application tabs. The 6 Software Navigation keys’ colors and functions correspond to those of the Software Navigation buttons on the application. The Left and Right arrow keys allow you to select tests.
Software Function Keys – Color Coded The Software Function keys allow you to control the different software functions on the application. The 12 Software Function keys’ colors and functions correspond to those of the Software Function buttons on the application.
Sweep Speed / Sensitivity Level
Sweep Speed Arrow Keys The Right and Left arrow keys allow you to modify the sweep speed. The Right arrow key increases the sweep speed. The Left arrow key decreases the sweep speed. Sensitivity Level Arrow Keys The Up and Down arrow keys allow you to modify the level of sensitivity. The Up arrow key increases the sensitivity level. The Down arrow key decreases the sensitivity level.
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Focus Instructions for Use
Stimulation
Stimulation Indicator The Stimulation indicator yellow light (LED) blinks once for Single Stimulation, and intermittently for Repetitive Stimulation.
Single Stimulation Key When the Single Stimulation key is pressed, a single stimulus is released, and the indicator blinks once. The Single Stimulation key can also be used to stop Repetitive Stimulation.
Repetitive Stimulation Key When the Repetitive Stimulation key is pressed, repetitive stimulus is released and the indicator blinks intermittently. To stop repetitive stimulation, press either the same Repetitive Stimulation key, or the Single Stimulation key.
Stimulation Intensity / Duration / Repetition Rate
Stimulation Intensity Control Knob The Stimulation Intensity control knob allows you to adjust the intensity of the stimulation released. Rotate the control knob to the right to increase the stimulation intensity. Rotate the control knob to the left to diminish the stimulation intensity.
Reset Stimulation Intensity Key Press the Reset Stimulation Intensity key to reset the stimulation intensity to its base level. WARNING When operating the current stimulators be careful not to expose the patient to high currents. Before connecting or disconnecting the stimulation electrode, always reset the stimulator.
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Focus Instructions for Use
Stimulation Duration Arrow Keys The Stimulation Duration Up and Down arrow keys allow you to increase / decrease the duration of the stimulation. The Up arrow key Increases the stimulation duration. The Down arrow key decreases the stimulation duration.
Stimulation Repetition Rate Arrow Keys The Stimulation Repetition Rate Up and Down arrow keys increase and decrease the stimulation repetition rate. The Up arrow key increases the stimulation repetition rate. The Down arrow key decreases the stimulation repetition rate.
Loudspeaker / Volume / Cursor Mode / Trace / Marker / Trigger
Loudspeaker Mute Key / Indicator Press the Loudspeaker Mute key to switch between the On and Off function. The yellow light (LED) indicates the loudspeaker is muted. To adjust the volume, see the Control knob function below.
Volume Indicator The green light (LED) indicator is on when the volume function is enabled –see the Control knob function below.
Volume / Cursor Control Knob Press the Control knob to switch between the Volume and the Cursor Mode functions. When Volume is enabled, rotate the knob to adjust the volume level. When Cursor Mode is enabled, rotate the knob to move the traces / markers or the trigger cursor.
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