HearTwave II Specifications

Transcription

1 HearTwave II s Product Indication of origin: Cambridge Heart, Inc., 100 Ames Pond Drive, Tewksbury MA Model or type reference: HearTwave II Classification: IIa Dimensions: Type CF equipment with defibrillation protection Depth: 62.2 cm (24.5 in.) Height: cm (53 in.) Width: 49.5 cm (19.5 in.) Shipping Weight: kg (240 lbs.) System Components System Cart: Alternans Processor: Power Supply: Patient Module: Patient Leadset: Output Devices: Input/Storage Devices: Provides housing/mounting for processor, output devices (monitor and on-board printer), keyboard, navigation device, power supply and patient module. Cart-housed PC to provide all data processing, data communication, data management and data storage required by the system. Medical-grade power supply with universal power input for the alternans processor and output devices. PM-3 14-lead Micro-V leadset 14-lead stress test leadset 10-lead stress test leadset Thermal printer Laser printer Wireless device for remote printing LCD monitor Keyboard Windows navigation device R/W CD drive PM-3 Patient Module Size: Fits in a volume 5.2 x 3.25 x 1.2 Weight: Circuit assembly: Data cable: < 22 oz. with patient leads and 4 feet of unsupported data cable Designed with a single circuit board assembly 15 ft. nominal length Meets USB requirements for high-speed application Standard USB host-end interface HWII s 1 of 6 PN Rev A

2 Enclosure: Label: Belt & buckle: Module end plugs into PM-3 circuit board w/quick-disconnect connector Strain relief at point-of-entry into PM-3 enclosure Each end withstands 1,000 flexes through +/- 90 degrees (per ANSI/AAMI EC ) Each end withstands an axial pull of 15 lbs. (per ANSI/AAMI EC ) Has openings for patient connector, data cable and a status LED. A belt capture bracket is added during assembly Has the supplier name, a model or type number and the product type CF marking 60 long, 1¼ wide, silver with a black flat-faced buckle ECG Amplifier Lead Systems: Packaging: A/D sample rate: Gain: Calibration accuracy: Linear input range: Electrode offset range: Common mode rejection: Input impedance: A/D precision: Slew rate: Noise: Defib protection: Leads off: Pacer detection: Dielectric withstand: Standard 12 lead, Standard 12 lead plus Frank xyz, or 14 lead (same as previous plus FI, H, M & E). Meets requirements of IEC Patient Module with amplification and digitalization; serial interface to USB connector. 32,000 samples per second (1000 Hz per channel). +/- 3% referred to input. +/-5% referred to input. +/-5 mv min. +/- 300 mv min. 90 db min. 10 Mohm at 60 Hz. LSB of 2.5 uv. 320 mv per second. <15 uv p-p RT1 with 10K ohm input impedance; <25 uv p-p with 51K ohm input impedance. Withstands repeated discharges of 5000V and 400J. Recovers within 8 seconds. Leads off detected. Detects and displays pacer spikes of between 0.5 to 2.0 ms duration and between 2 and 250 mv in amplitude V RMS between isolated inputs and chassis ground. Power Supply Input Voltages: VAC or VAC Frequency: 60/50 +/-1 Hz Power Consumption: 600 watts maximum Protection: Dual primary current fuses 6.3/5.0 Connector: IEC power inlet HWII s 2 of 6 PN Rev A

3 Power Cord: 10-foot UL-listed, detachable with hospital-grade plug Waveform Display Type: Refresh rate: Real-time ECG display: 15-inch flat-panel LCD. 70 Hz min, non-interlaced. Real Trace real-time display shows up to 6 simultaneous leads of 6.5 seconds each, or 12 leads of 2.1 seconds each with 9.4-second rhythm lead. Sweep speed 25mm/sec or 50 mm/sec (+/- 5%). Gain 5, 10 and 20 mm/mv +/-5%. Bandwidth Thermal Recorder Size: Type: Resolution: Speed: ECG Channel Width: 0.05 to 100 Hz. Meets ANSI/AAMI diagnostic standards. 8.5 x 11 inch. 216mm Direct Thermal Linear Array. Vertical: 8 dots/mm; Horizontal: 16 dots/mm. 25, 50 mm/sec. 40 mm min. ECG Gain: 5, 10 and 20 mm/mv +/-5%. ECG Slew Rate: ECG Frequency Response: Standardizing Voltage: Paper Capacity: Laser Printer 320 mv/sec min at 5 mm/mv to 160 Hz. (+1, -3 db) referred to ECG input (meets ANSI/AAMI EC11). 1 mv +/- 5% (referred to input). 300 sheets min. Paper size: Resolution: Speed: Main input tray capacity: Duty cycle: 3 x 5 inches (76 x 127 mm) minimum; 8.5 x 14 inches (216 x 356 mm) maximum dpi effective output quality. First page out in less than 8 seconds. 150 sheets of regular weight 20 lb (75g/m 2 ) paper. 7,000 single-side pages per month (maximum). HWII s 3 of 6 PN Rev A

4 Compatibility Electronic Ergometers (w/ appropriate interface cables): Treadmills (w/appropriate interface cables): NIBP Devices (w/appropriate interface cables): Echo Systems: Seca CardioTest 100 Ergoline 900 Lode Corival 400 Trackmaster TM400 Standard Trackmaster TM400 Slow Start Trackmaster TM425 Trackmaster TMX425 Trackmaster FVX328 Marquette 1800 (serial) Marquette 1900 Marquette 2000 Parker PM Quinton TM55 Quinton Q50 Quinton Q55 Quinton Q55XT Quinton Q65 SunTech Tango CardioDyne NBP Sonos 4500/5500 and Acuson XP Trackmaster TMX425 and FVX328 Treadmills Speed: Incline: Patient capacity: Power cord: Interface cable Handrail Emergency stop button Tread surface size Standards.5 to 12 MPH, continuously adjustable during exercise. 0 to 25%, continuously adjustable during exercise. 500 lbs. 220V-20 amp circuit breaker and dedicated line. Plugs separately into AC outlet; supplied with 12-foot cable and hospital-grade plug. 12-foot cable from cart to treadmill (optional). One front and two side handrails included. Pushbutton on rail accessible to both patient and operator. TMX425: 22 in. wide x 63 in. long. FVX328: 22 in. wide x 55 in. long. ETL listed. Signal Processing and Numeric Outputs Line frequency cancellation Adaptive line frequency cancellation on ECG input. User selectable at 50 or 60 Hz, with a rejection ratio of 60 db min. for Hz or Hz. Baseline filter User-selectable time domain linear phase filter, meeting ANSI/AAMI EC 13:2000, section HWII s 4 of 6 PN Rev A

5 WaveSTar Signal Processing Technology Artifact filter (40 Hz) Automatic baseline positioning Beat detector Heart rate meter Median beat calculation Shape discrimination J-Point detection Isoelectric point detection ST-Level measurement Worst Case Lead ST-Slope measurement T-wave alternans measurement requirements, applied independently to the printer or display outputs. Provides a unique means of addressing muscle artifact and noise that can obscure the ECG waveform during strenuous stages of exercise stress testing. This is accomplished by isolating the high-frequency QRS complex and independently smoothing the low-frequency ST segment and T-wave while maintaining ECG diagnostic integrity. WaveSTar is applied independently to the recorder output and screen. Linear phase low-pass filter at 40 Hz, baseline and WaveSTar, applied independently to the printer or display outputs. Automatic adjustment of the baseline position for centering the QRS complex. Threshold detection on bandpass-filtered Absolute Spatial Vector Velocity (ASVV). Automatic substitution of detection leads during leads-off or lead absence. Meets or exceeds EC13:2000 section requirements. Within input range of BPM, readout error is 5%, exceeding requirements of EC13:2002 section Incremental update of median QRS complexes with suppression of artifact, ectopy and aberrancy in all leads. Uses cross-correlation to template technique. Exclusion of beats with less than 90% correlation coefficient or more than 10% prematurity in median beat update. Automatic, based on Absolute Spatial Vector Velocity (ASVV) of median beat. Continuously updated. User-selectable for ST measurements. Automatic, based on Absolute Spatial Vector Velocity (ASVV) of median beat. Continuously updated. Average level of ST-segment relative to isoelectric point, continuously updated. The lead that exhibits the largest ST change from rest, measured at any time during a protocol, from the beginning of exercise to the current time. Leads named for inclusion are specified in the site file. Most negative slope in any 40 msec interval between the J-point and 80 msec beyond the J-point. Is calculated in microvolts using the Analytic Spectral Method. Rate pressure product (RPP) Heart rate times systolic blood pressure divided by 100. METS calculation Reports and ECG Printouts Treadmill protocols: computed as a function of speed and grade. Ergometer protocols: computed as a function of workload and weight. Between stages, the METS value is interpolated. The correct METS value of the stage is reached after a stage time of 120 seconds (default value, can be changed by the user). MTWA Stress MTWA trend summaries, including interpretation, are available for printing and/or editing. Through Reports screen, full disclosure, exercise summary, medians summary, ST trends, ST- HR loops, worst case, maximal exercise and timed 12 leads are available for review and/or printing. HWII s 5 of 6 PN Rev A

6 Safety and Environmental Standards Performance specifications: Operating temperatures: degrees C ( degrees F) Relative humidity: Atmospheric pressure Meets the American National Standards for Diagnostic Electrocardiographic Devices (ANSI/AAMI EC ), and, where relevant, for Cardiac Monitors, Heart Rate Meters and Alarms (ANSI/AAMI EC ) 25% to 80% non-condensing 700- to 1060-hPA Chassis leakage current <100 ua RMS when measured in accordance with EN Patient leakage current Dielectric withstand RF emissions Electrostatic discharge <10 ua sink current RMS when measured at the patient end of the patient cable in accordance with EN V RMS from isolated patient connections to chassis ground; 4000 V RMS from patient to mains; 1500 V RMS from AC primary to chassis ground. Meets requirements of EN 55011, Group 1, Class A for radiated and conducted emissions. Withstands, without irreversible failure, air discharges of 2, 4, 6 and 8 kv and contact discharges of 2, 4 and 6 kv to any point accessible to the operator or patient when tested in accordance with EN Tilt test: 10 degrees with monitor in worst-case position (per EN ) Drop test: 2 cm per EN Protective Packaging: This side up Fragile Keep dry Stacking limitation HWII s 6 of 6 PN Rev A