StimLab™ Specifications

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 

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
(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

  • Stimulation Threshold
  • Wenckebach Periods
  • Anterograde/Retrograde
  • Programmed V Stimulation
  • SN Recovery Times
  • Burst Pacing (to 30ms)
  • SN Conduction Times
  • Auto-decremental Pacing
  • His-coincident extras
  • AV sequential Pacing
  • Overdrive Pacing
  • Combined AV drive-train
  • AICD-type ATP
  • AF/VF induction
  • Biventricular pacing

Protocol Automation

  • Auto decrement / increment: S1, S2-S7, stimulation current
  • SNRT S1 intervals and RT calculation
  • Auto pace and sense - site selection in protocols
  • His-coincident extra-stimulus timing calculation
  • ATP S1 calculation from % of TCL
  • Trigger output on sensed ectopic beats
  • Stop On Tachycardia
  • All automation subject to instant operator adjustment

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:  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:

  1. Specifications may change without notice.
  2. Computer specifications will vary according to availability.

StimLab Specifications Ver 1.1 3.12.07, based on:

  • EPS320 Device Specifications Ver 3.0 04.04.08
  • EPS320B-EU/US, PCB Ver P3.15, Sch Ver 3.08

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