Data Sheet Bispectral Index (BISx) Module 1.00 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.

Data Sheet Bispectral Index (BISx) Module 1.00 Module use is restricted to one patient at a time. 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...

Data Sheet Bispectral Index (BISx) Module 1.00 Patient leakage current <100 Operating voltage +5 VDC, 12 VDC Power consumption 4.5 W maximum Water ingress Meets EN 60529 IPX1 only when installed in 91393 Xprezzon, 91390 Qube, and 91389 Qube Mini patient monitors For a full list of available supplies and accessories, go to https://www.spacelabshealthcare.com/supplies. (Kit includes BISx pod, patient interface cable (PIC), and host monitor cable.) BISx patient interface P/N 719-0004-xx This product ships with a complete set of comprehensive documentation. You can also access documentation online...

Data Sheet Bispectral Index (BISx) Module 1.00 Regulatory Approvals The BISx device has been tested and certified by Underwriter’s Laboratories to meet IEC/UL 60601-1 for product safety. CSA certified. Meets IEC 60601-1, CAN/CSA C22.2 No. 60601-1, and ANSI/AAMI ES60601-1 for electrical safety. CE marked in accordance with the Medical Device Directive 93/42/EEC. Does not contain hazardous substances - China BISx module complies with the following standards: Applicable standard editions or document number/revision and description IEC 60601-1:2005 +AMD1:2012 Medical electrical equipment – Part 1:...