| System | |
|---|---|
| Stimulus Controller: | Embedded micro-controller in SGU |
| User Interface: | PC windows-style graphical display |
| Weight: | 25 kg gross |
| Power: | 110-240VAC 50-60Hz, 90VA max. (40VA standby), Class II |
| Isolation transformer: | Toroidal 1:1 medical grade, 110-240 VAC, 100 VA max. |
| Computer | |
| CPU: | VIA-Eden ESPTM 533 MHz or similar |
| Weight: | 5.65 kg, with monitor and keyboard |
| Dimension: | CPU: 23.4x4.8x17.5 cm, 15” Monitor, 101 Keyboard |
| Hard Disk: | 64Mb CompactFlash Card |
| Power Source: | 100-240 VAC to 12V DC 5.0A PSU (via isolation transformer) |
| O/S Software: | Custom RTOS / Datalight ROM-DOS |
| Stimulus Generator Unit | |
| Main power source: | 100-240 VAC to 15 VDC 1.2A PSU |
| Backup power: | 12V 2.1 Ah sealed lead acid |
| Emergency power: | 9V LiMnO2i PP3, 10y life |
| Weight: | 5.3 kg including batteries & PSU |
| Dimensions: | 31.5cm x 34.0 cm x 9.5cm |
| Power Consumption: | 800 mA peak during operation 40 mA in standby mode |
| Operating Time: | Indefinite with mains connected Two(2) hours on backup battery |
| Pacing Channels | |
| Isolated Channels(3): | (i)Atrial (ii)Ventricular via green Redel 4 pin socket (iii)Emergency Fixed Pace Output to Ventricle, via red Redel 4 pin socket |
| Power Source: | Internal DC-DC converters |
| Circuit Isolation: | Compliant with IEC601-1, Type CF, 5kV, common & differential mode |
| Computer Controlled Stimulus Pulses | |
| Current: | 0.1 to 25 mA |
| Current Steps: | 0.1 mA |
| Accuracy: | ± 2% or ± 0.2 mA, which ever is greater |
| Pulse Duration: | 0.5 ms, 1-10 ms in steps of 1ms |
| Accuracy: | ± 0.15 ms |
| Load Impedance: | 200-1000 Ω, <700 Ω for max current |
| Max Output Voltage: | 27V |
| Inter-Stimulus Intervals | |
| S1 Range: | 180 - 9990 ms(Pace) 30 - 9990 ms (Burst Pace) |
| Stability: | Quartz computer clock, ± 30 parts per million @ 25o C Extra-Stimuli: 6 max, S2-S7, independent Coupling interval: 30 - 9990 ms, Accuracy ± 1 ms or 0.1% whichever is greater |
| Pre-Programmed Protocols | |
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| Protocol Automation | |
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| Backup Manually Controlled Stimulation | |
| Power Source: | 12V 2.1Ah sealed lead acid battery |
| Pulse Current: | 0.1 to 25mA |
| Accuracy: | ± 2%, or ± 0.2mA which ever is greater |
| Pulse Duration: | 2ms, fixed |
| Pulse Interval: | 100 - 1400ms, accuracy:+1% |
| ECG Sense/Trigger | |
| High level external: | Two inputs: (i) Ext_ECG1, (ii) Ext_ECG2, Connector: 6.5mm Phone socket Input Ranges: 1V and 2V pp for FSD Maximum Input: 2V AC pk - pk Frequency Range: 1 to 250 Hz, typical |
| Pacing catheter tip: | Two channels: (i) Atrial, (ii) Ventricular Input ranges: 2mV to 36mV, 4 gains Frequency Range: 10 to 250 Hz, typical |
| Either Source: | Threshold: Adaptive software peak detect Lockout Period: 50 - 1000ms in software Pace Sync Delay: 50 - 5000ms in software Sampling- display: 500Hz, 8 bit |
| Auxiliary SYNC Inputs/Outputs | |
| Sync1 Output: | 6.5 mm Phone socket |
| Timing: | On any drive train pulse, on halt of pacing, on extra in R-synced S2 |
| Pulse: | +5V CMOS level, 50 ms duration |
| Sync2 & 3 Output: | Used for internal functions |
| Sync1 & 2 Input: | Used for internal functions |
| Emergency Backup Pacing | |
| Power Source: | 9V Lithium Manganese PP3 battery, 10 years life |
| Pacing Pulse: | 5mA ± 1.0 mA, 2ms ± 0.5ms, 100 ± 20 ppm |
| Pace output: | Separate red Redel 4 pin socket |
| Control: | Pacing activated by connection of a load <1M Ω, i.e. insertion of plug connected to patient |
| Environmental | |
| Operating Temperature Range: | +5°C to 35°C (30% to 80% RH) |
| Storage Temperature Range: | -10°C to 60°C (10% to 85% RH) |
| Storage Altitude: | 1 Atm to 13,000 m |
| Certification | |
| MDD Device Class: | Class IIb |
| IEC60601-1: | certified |
| Health Canada: | Class III |
| EMC compliance: | certified |
| CE Marking: |  |
| US Regulations: | 510(k) Accepted |
Notes:
Datalight and ROM-DOS are registered trademarks of Datalight, Inc. V3.0 |
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