Catalog excerpts

SL BISx - 1

Summary The Bispectral Index (BISx™) module acquires real-time electroencephalogram (EEG) data for adult and pediatric patients and processes it into a Bispectral Index® (BIS®) number between 0 and 100. BIS analysis is a mathematical calculation derived from the frequency, power, and phase throughout the entire frequency range of the EEG. The BISx Module may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. Features Product Configurations Display Formats Single zone: The BIS trend and numeric are displayed. Three-zone (bedside monitor only): The BIS and EMG trends are displayed, as well as one EEG waveform (waveform is user selectable). Data Storage Predefined EEG trends for easy setup; BIS, Spectral Edge Frequency (SEF), Median Power Frequency (MF), Electromyographic Strength (EMG), Signal Quality Index (SQI), and Suppression Ratio (SR) data; Burst Count (BC) data is available when using the BIS Extend Sensor. Electrode Impedance Testing Manual or Auto modes; the combined BIS sensor impedance measurements are checked continuously; the impedance of the ground element is checked every 10 minutes. Module Configuration Manager Provides the ability to define the module’s user-configurable settings. Once a module has been configured, these settings control its operation whenever the module is powered ON. Patient Compatibility Adult and pediatric. Note: Module use is restricted to one patient at a time. Product Specifications Number of Channels Sweep Speeds

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SL BISx - 2

EEG High Pass Display Filters EEG Low Pass Display Filters Input Impedance Common Mode Rejection Input Noise Alarm Display Options Audible alarms for HI and LO alarm limits, and caution alarm Externally powered; rate for continuous operation Type BF; defibrillator-proof Body Floating applied part Electrical Specifications Patient Leakage Current Operating Voltage Power Consumption Environmental Requirements Storage Temperature Operating Temperature Humidity

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SL BISx - 4

Regulatory Approvals The BISx device has been tested and certified by Underwriter’s Laboratories to meet IEC/UL 60601-1 for product safety and IEC 60601-2-26, Second Edition, for EEG performance. CSA certified. Meets IEC 60601-1, CAN/CSA C22.2 No. 60601-1, and ANSI/AAMI ES60601-1 for electrical safety, and IEC 60601-2-26: EEG. C€ CE marked in accordance with the Medical Device Directive 93/42/EEC. RtffHS2 2011/65/EU Does not contain hazardous substances - Europe Does not contain hazardous substances - China Please refer to for a full...

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