SigmaPace™ 1000
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External Pacemaker Analyzer Technical Data Fluke Biomedical’s premier SigmaPace™ 1000 analyzes both transvenous and transcutaneous external pacemakers and comes loaded with features to save time and money. This powerful handheld tool conducts the full suite of tests specified by major pacemaker manufacturers in less than half the time it would take using originally prescribed testing methods. Output data is displayed on three selectable screens for easy viewing, including an AV delay time readout providing a performance snapshot for both pacer channels. With capability for long-term trend testing, the SigmaPace 1000 can interrogate a pacer for up to 11 days, capturing data pulse by pulse to detect intermittent and hard-to-find problems. For maximum efficiency, the SigmaPace 1000 doubles as a training tool. Interactive ECG simulation lets users test patient monitoring equipment as well as teach nurses how to operate the pacemaker. • Transcutaneous and transvenous external pacemaker tests • Pulse-output tests (rate, current, volts, energy, pulse width, and AV interval) • Amplitude sensitivity and refractory tests • Demand and asynchronous-mode tests • DC load current test • Output-leakage tests • Line-frequency noise-rejection tests • Wide range of test loads, from 50 Ω to 1500 Ω, specified by manufacturer for transcutaneous pacers • Full range of IEC specified test loads for transvenous pacers 200 Ω, 500 Ω, and 1000 Ω • Pacer output displayed on three different screens • AV readout showing both pacer channels on one screen • Long-term trend test to detect intermittent errors and hard-to-find problems • Interactive ECG pacer simulation with 5-lead output for patient monitor evaluation and pacer operation training • 8-line x 21-character display

Specifications Transcutaneous pacer tests Output pulse measurement Current Accuracy Ranges Accuracy Ranges Accuracy Ranges Accuracy Demand and asynchronous mode tests Waveform (physiological simulation) Amplitude Modes of operation Active outputs Pacemaker compatibility 4 mA to 9.99 mA; 10 mA to 99.9 mA; 100 mA to 250 mA ± 2 % of reading or ± 50 μA (whichever is greater) 5 PPM to 99.9 PPM; 100 PPM to 300 PPM ± 0.5 % of reading or ± 0.3 PPM (whichever is greater) 1 mS to 9.99 mS; 10 mS to 99.9 mS ± 0.5 % of reading or ± 14 μS (whichever is greater) 1 μJ to 999 μJ; 1 mJ to 999 mJ; 1.00 J to...

Active outputs 5-lead ECG; ventricular test load Paced refractory period test (PRP) Range Accuracy Physiological simulation Outputs Pacemaker compatibility 20 mS to 500 mS 5 % of reading or 1 mS (whichever is greater) Selection Single pulse, R-wave, SSQ Pulse width 40 mS 5-lead ECG; ventricular test load Pulse rates 30 BPM to 200 BPM Intended type VVI (pace and sense) Sensed refractory period test (SRP) Range Accuracy Physiological simulation Active outputs Pacemaker compatibility 15 mS to 500 mS ± 5 % of reading or ± 1 mS (whichever is greater) Selection Double pulse, R-wave, SSQ Pulse...

Demand/async mode tests Channels Waveform Atrial output Vent output Interactive simulated rates Output Pulse rate Intended pacemaker types Single and dual Sine square (SSQ) Simulated P-wave Width Amplitude Simulated R-wave Width Amplitude Interval Default settings 40 mS 2.5 mV peak AV 90 mS (fixed) Underdrive = NSR @ 85 % of pulse interval/rate; overdrive = NSR @ 115 % of pulse interval/rate Manual NSR simulations adjustable in 1-BPM increments Limits Underdrive (min) = 10 BPM; overdrive (max) = 300 BPM Ventricular channel test load; atrial channel test load 30 PPM to 200 PPM Demand VVI...

Ventricular channel (physiological simulation) Waveform selections Available test load(s) Amplitude Intended pacemaker type(s) Selection Rate Timing R-wave, S-wave, and T-wave 30 BPM to 120 BPM Waveform delayed from the ventricular demand pacemaker pulse by 80 % of the pulse-to-pulse interval or 400 mS (whichever is shorter) Active output Selected ventricular test load Square (SQU); triangle (TRI); haversine (HSN); sine square (SSQ) (default setting); asymmetrical triangle (ISO) – fixed width: 2 mS rise time/13 mS fall time 200 Ω, 500 Ω (default setting) and 1000 Ω ± 1 % Pacer load...

Refractory period test (atrial channel) Test selections Period Accuracy Resolution Physiological simulation Additional waveform selections Amplitude Active outputs Intended pacemaker types Pacemaker rates Available test load Paced refractory period; sensed refractory period 20 mS to 500 mS ± 5 % of reading (or ± 1 mS, whichever is greater) ± 1 LSD Selection Square wave (default setting) Atrial channel Simulated P-wave Width 1 mS Amplitude 20 mV peak Active outputs Atrial channel (4 mm banana jacks) only Square (SQU); triangle (TRI); haversine (HSN); sine square (SSQ); asymmetrical triangle...

Resolution Display format Test selections Test load/input configurations Baseline/test selection Dynamic test dating algorithm Specified applied pacemaker rate 1 LSD (0.1 μA) 3 digits Static Continuous (power OFF) Dynamic Gated (power ON) Atrial + and atrial Ventricular + and ventricular Atrial + and ventricular + 500 Ω Measurement made 400 mS prior to the pacemaker pulse leading edge; 16 measurements averaged at a 4 mS rate for a total of 64 mS 80 PPM Current drain test DC current ranges Polarity Indicator Resolution Display format Accuracy Input dc voltage Selectable test loads Battery...

General information Temperature Humidity range Modes of operation User interface Keys Serial port Dimensions (WxDxH) Weight Safety Operating 15 °C to 35 °C (59 °F to 95 °F) Storage 0 °C to 50 °C (32 °F to 122 °F) < 90 % noncondensing Manual, remote (via standard RS-232 serial port) Display 21-character x 8-line LCD readout; brightness/ viewing angle adjustment Eight push buttons [F-2, F-3 (UP arrow), F-4 (UP arrow), two DOWN arrows, ESCAPE, and ENTER] Type RS-232 Connector type DB-9 (male) Baud Rates 2400, 9600, and 19200 Data control Xon/Xoff External battery charger source/power supply...