Safety Specifications. The BISx and BISx4 comply with the essential requirements of the Medical Device Directive 93/42/EEC, as well as IEC 60601-1 and IEC 00000-0-00. • They are both Type BF applied parts. Both the BISx and BISx4 have internal optical coupling and an isolation transformer for patient isolation. • Both are protected against damage from defibrillation as long as the sensor is not located between the defibrillator pads and is resistant to artifact from electrosurgery. • United States federal law restricts these devices to sale by or on the order of a physician. • BISx, BISx4, and cables are latex free. Environmental Specifications Liquid Ingress: IEC 529 IPX4 Temperature 0 to 40 degrees C operating -40 to 70 degrees C storage Humidity 10% to 95% non-condensing operating 10% to 95% non-condensing storage Pressure 480 to 1067 hPa operating (Approx -1250 to 20,000 feet) 116 to 1067 hPa storage (Approx -1250 to 50,000 feet) Performance Specifications Measurement Ranges Bispectral Index (BIS): 0 to 100 unitless scale Electromyographic Strength (EMG): 25 to 100 dB where 1 µV2=40dB Signal Quality Index (SQI): 0 to 100% Suppression Ratio (SR): 0 to 100% Spectral Edge Frequency (SEF): 0.5 to 30.0 Hz Total Power: 40 to 100 dB where 1 µV RMS=40dB Burst Count: 0 to 30 Noise (EEG Waveform) < 0.3 µVRMS (2.0 µV peak-to-peak) BIS Numeric Update Frequency Once per second EEG Bandwidth 0.25 to 100 Hz (- 3dB) Patient Leakage <10uA 11/13 EXHIBIT C CONTACT PERSONS/ADDRESSES Contact Persons and Responsibilities at Aspect: Person Title Responsibility Email Xxx Xxxxxxx Director, Sales Operations Contract xxxxxxxx@xxxxxxxx.xxx Xxxxx Xxxxx Product Manager, OEM Marketing xxxxxx@xxxxxxxx.xxx Xxxxx Xxxxxxxxx Director, OEM Engineering Project Manager xxxxxxxxxx@xxxxxxxx.xxx Xxxxxxxxx Xxxxxxx Senior Director, RA/QA Quality and Regulatory Matters xxxxxxxx@xxxxxxxx.xxx Xxxxx Xxxxxxx OEM Engineer Technical Design Issues xxxxxxxx@xxxxxxxx.xxx Mailing Address: Aspect Medical Systems, Inc. Xxx Xxxxxx Xxxx Xxxxxxx, XX 00000 Contact Persons and Responsibilities at Draeger: Person Title Responsibility Email Marketing Engineering Contracts Project Management Mailing Address: Xxxxxxx Medical Systems, Inc. 0 Xxxx Xxxxx Xxxxxxx, XX 00000
Safety Specifications a. Contractor personnel must operate all equipment on Borough streets and public grounds in a manner consistent with law and safety standards. Any violation of safety standards may be deemed cause for termination of the contract.
Safety Specifications. Purchase orders for safety glazing materials must reference a drawing provided to XXXXXX Gemtron with any safety standard to which the glass must be manufactured, certified and labeled.
Safety Specifications. The BISx and BISx4 comply with the essential requirements of the Medical Device Directive 93/42/EEC, as well as IEC 60601-1 and IEC 00000-0-00. • EMC RF Emissions: CISPR-11 Class A • They are both Type BF applied parts. Both the BISx and BISx4 have internal optical coupling and an isolation transformer for patient isolation. • Both are protected against damage from defibrillation as long as the sensor is not located between the defibrillator pads and are resistant to artifact from electrosurgery. • United States federal law restricts these devices to sale by or on the order of a physician. • BISx and cables are latex free. Environmental Specifications Liquid Ingress: IEC 529 IPX4 Temperature 0 to 40 degrees C operating -40 to 70 degrees C storage Humidity 10% to 95% non-condensing operating 10% to 95% non-condensing storage Pressure 480 to 1067 hPa operating (Approx -1250 to 20,000 feet) 116 to 1067 hPa storage (Approx -1250 to 50,000 feet) Performance Specifications Measurement Ranges Bispectral Index (BIS): 0 to 100 unitless scale Electromyographic Strength (EMG): 30 to 80 dB where 1µV2=40dB Signal Quality Index (SQI): 0 to 100% Suppression Ratio (SR): 0 to 100% Spectral Edge Frequency (SEF): 0.5 to 30.0 Hz Total Power: 40 to 100 dB where 1µV RMS=40dB Burst Count: 0 to 30 Noise (EEG Waveform) < 0.3 µVRMS (2.0µV peak-to-peak) BIS Numeric Update Frequency Once per second EEG Bandwidth 0.25 to 100 Hz (- 3dB) Patient Leakage <10uA BIS/EEG Module Kit The BIS/EEG Module Kit is designed specifically for OEM applications and allows the integration of Aspect’s BIS monitoring technology into OEM equipment. The BIS/EEG Module Kit will interface to the patient via the Aspect BIS Sensor and to the OEM equipment utilizing a serial (RS-232) 3-wire interface and the necessary power connections. The BIS/EEG Module Kit consists of a Digital Signal Converter (DSC-XP) that is placed in proximity to the patient and a small circuit board that resides in the OEM equipment. The DSC-XP is a small (palm sized) front-end to the BIS Engine circuit board that provides the patient interface and performs the high performance analog to digital conversion of the EEG signals. The EEG signals are transmitted in digital format from the DSC-XP to the BIS Engine circuit board via a 12 foot cable that is hard wired at the DSC-XP. The small BIS Engine circuit board performs digital signal processing on the digitized EEG signal and outputs the Bispectral Index to the OEM system via the RS-232 s...
