| StimLab System | |
|---|---|
| Stimulus Controller: | Embedded micro-controller in SGU |
| User Interface: | Computer Touch Graphical Interface |
| Power: | 110-240VAC 50-60Hz, 95VA max, (40VA standby), Class II |
| Isolation transformer: | 110-240 VAC, 100 VA, IEC60601-1 |
| StimLab Cabinet | |
| PC: | Bona Lex Light System SBC, CPU VIA Eden ESP™ 533 MHz or similar |
| Hard Disk: | >=64Mb Compact Flash Card |
| Power Source: | 100-240 VAC to 12V DC 5.0A PSU |
| O/S Software: | Custom RTOS / Datalight ROM-DOS |
| Remote Trunk Cable: | Length: 17m (55.7 feet), 10mm o.d. Connector: Single Cannon Trident series bayonet 23 pin cable reverse connector, max diam. 34.3mm |
| Local Screen Cable: | 1.25 meters (4 feet), integrated cable |
| Weight: | 7.3kg (11.0kg with all attached external cables) |
| Dimension: | 400 x 300 x 122 mm |
| Video Extension: | Gefen Extendit VGA Extender SR |
| Remote Touch Screen | |
| Monitor type: | ELO Entuitive ET1529L, 15" LCD |
| Touch technology: | AccuTouch Five-Wire Resistive |
| Power rating: | Input: DC 12V / 2A (max.) only. |
| Mounting: | Integral stand or VESA 75mm mount |
| Cable Length: | 4 meters (13 feet) |
| Dimension: | 354 x 301 x 285mm |
| Power Consumption: | On: 50W max, Sleep: 4W, Off: 2W |
| Sealing: | Resistant to splashes, IPX0 |
| Standard stand tilt: | 0° to 45° from vertical |
| Weight: | 16.2 lbs (7.4kg) |
| Optional Remote Touch Screen Roll Stand | |
| Height: | 31" (79cm) to 45.5" (115.5cm) |
| Lift Mechanism: | Gas spring assisted |
| Counterweight: | Built-in 10 lbs (4.5kg) |
| Screen tilt range: | -20° to +30° from vertical |
| Weight: | 38lb (17.3kg) |
| Mount: | VESA 75mm Display mount |
| Stimulus Generator Unit | |
| Main power source: | 100-240 VAC to 15 VDC 1.2 A 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 (12W) peak during operation 40 mA (0.6W) in standby mode |
| Operating time: | Indefinite with mains connected. Two(2) hours on backup battery |
| Pacing Channels | |
| Isolated Channels(3): | (i) Atrial and (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: | Opto-coupled, 5kV, common & differential mode |
| Computer Controlled Stimulus Pulses | |
| Current: | 0.1 to 25 mA |
| Current Steps: | 0.1 mA |
| Accuracy: | ± 2%, or ± 0.2mA which ever is greater |
| Pulse Duration: | 0.5 ms, 1 - 10 ms in steps of 1 ms |
| Accuracy: | ± 0.15 ms |
| Load Impedance: | 200-1000 W, < 700 W 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 @ 25°C |
| Extra-Stimuli: | 6 max, S2-S7, independent |
| Coupling interval: | 30 - 9990 ms |
| Accuracy: | ± 1 ms or 0.1% whichever is greater |
| Patient Interface protection | |
| Circuit Class: | IEC60601-1 Class CF |
| Defib protection: | 5kV / 20ms (360J) according to IEC60601-1 |
| RF Ablation protection: | 350 Vp-p/ 200 s, 300 kHz - 1 MHz equivalent to RF Ablation energies up to 150W into <= 300 Ohm loads |
| Input impedance: | > 10KΩ (at 500 kHz) |
| RF Protection Filter: | Differential: -52dB at 485kHz Common Mode: -20dB at 485kHz |
| Pre-programmed Protocols | |
|
|
| Protocol Automation | |
|
|
| 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: ±0.5V and ±1.0V pp for FSD Input Impedance: 47kΩ 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 - 5000 ms in software Sampling display: 500Hz, 8 bit |
| Auxiliary Sync Inputs/Outputs | |
| Sync1 Output: | 6.5mm 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 |
| Emergency Backup Pacing | |
| Power Source: | 9V Lithium Manganese PP3 battery, 10 years life |
| Pacing Pulse: | 5mA ± 1.0mA, 2ms ± 0.5ms, 100 ± 20 ppm |
| Pace output: | Separate red Redel 4 pin socket |
| Control: | Pacing activated by connection of a load < 1MΩ, 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 |
| CE Marking: |  |
| FDA Reg. Class/No.: | Class II, 21CFR 870.1750 |
| Health Canada: | Class III |
| IEC60601-1: | certified |
| EMC compliance: | certified |
| US Regulations: | 510(k) Cleared |
Notes:
|
|
StimLab Specifications Ver 1.1 3.12.07, based on:
|
|
