The SigmaPaceTM 1000 is a powerful handheld analyzer with a comprehensive range of test suites, measurement algorithms and test loads – as specified by the external pacemaker manufacturers – to fulfill your testing requirements both quickly and efficiently.

Unique full-featured biomedical test product Tests for both transcutaneous and transvenous external pacemakers Full range of user-selectable measurement algorithms and test loads for external pacemakers Dual-channel signal acquisition for capturing synchronous AV-sequential pulse data Interactive pacemaker and ECG simulation with 5-lead output Large 21-character x 8-line alphanumeric LCD readout Exclusive readout "HOLD" function Exclusive SigmaPaceTM 1000 test features: DC static/dynamic leakage, and current drain

Specifications
Modes of Operation	Manual  Remote (via standard RS232 serial port)
User Interface	Display:  - LCD readout  - 21 characters X 8 lines  - Brightness/viewing angle adjustment Keys:  Eight push buttons (F-2, F-3 [UP arrow], F-4 [UP arrow], two DOWN arrows, ESCAPE, and ENTER)
Transcutaneous Pacer Tests:	Output Pulse Measurement   Current:  - Ranges: 4.00 mA to 9.99 mA; 10.0 mA to 99.9 mA; 100 mA to 250 mA  - Accuracy: ± 2 % of reading or ± 50 µA (whichever is greater) Rate:  - Ranges: 5.0 PPM to 99.9 PPM; 100 PPM to 300 PPM  - Accuracy: ± 0.5 % of reading or ± 0.3 PPM (whichever is greater) Width:  - Ranges: 1.00 mS to 9.99 mS; 10.0 mS to 99.9 mS  - Accuracy: ± 0.5 % of reading or ± 14 µS (whichever is greater) Energy:  - Ranges: 1 µJ to 999 µJ; 1 mJ to 999 mJ; 1.00 J to 1.99 J  - Accuracy: 5 % of reading/computation Demand and Asynchronous Mode Tests   Waveform (Physiological Simulation):  - Normal sinus rhythm (NSR)  - Complete P-QRS-T complex Amplitude:  1.0mVpeak (lead I) Modes of Operation:  - Underdrive: NSR @ 85 % of pulse interval/rate  - Overdrive: NSR @ 115 % of pulse interval/rate  - Auxiliary Control: NSR adjustable in 1-BPM increments  - Auxiliary Rate Range: Underdrive 10 BPM (min); overdrive 300 BPM (max) Active Outputs:  5-lead ECG; ventricular test load; high-level ECG jack Pacemaker Compatibility:  - Pulse Rates: 30 to 200 PPM  - Intended Types: Demand: VVI (pace and sense); async: VOO (pace) Amplitude Sensitivity Test   Selections: R, S and T Waves  - Rate: 30 to 200 PPM  - Test Loads: (30) 50 Ω to 1550 Ω in 50-Ω steps Waveforms:  Square (SQU); triangle (TRI); haversine (HSN); sine square (SSQ) Amplitude:  - Range: 0.05 mVpeak to 5.0 mVpeak  - Accuracy: ± 5 % of setting  Resolution: 0.05-mV steps (0.05 to 0.95 mVpeak); 0.50-mV steps (1 to 5 mVpeak) Width:  - Range: 0.15 mS to 300 mS  - Accuracy: ± 5 % of setting  - Selections: 50  - Resolution: 0.05-mS steps (0.15 to 0.95 mS); 1-mS steps (1 to 19 mS); 5-mS steps (20 to 95 mS)  25-mS steps (100 to 300 mS) Active Outputs:  5-lead ECG; ventricular test load; high-level ECG jack Pacemaker Compatibility:  - Pulse Rates: 30 to 200 PPM  - Intended Type: VVI (pace and sense) Noise Immunity/Line Frequency Test   Waveform:  Sine wave  - Frequency: 50 and 60 Hz  - Accuracy: 0.5 Hz Amplitude Testload Output:  - Range: 0 (OFF) to 10 mVpeak-to-peak  - Accuracy: ± 5 % of setting  - Resolution: 0.5-mVpeak-to-peak steps  - Settings: (30) 50 Ω to 1550 Ω ± 1 % 5-lead ECG Output:  - Range: 0 (OFF) to 10 mVpeak-to-peak  - Accuracy: ± 5 % of setting  - Resolution: 0.50-mV steps  - Reference: Lead I (RA to LA) Active Outputs:  5-lead ECG; ventricular test load Paced Refractory Period Test (PRP)   Range:  20 mS to 500 mS  - Accuracy: 5 % of reading or 1 mS (whichever is greater) Physiological Simulation:  - Selection: Single pulse, R Wave, SSQ  - Pulse Width: 40 mS Outputs:  5-lead ECG; ventricular test load Pacemaker Compatibility:  - Pulse Rates: 30 to 200 BPM  - Intended Type: VVI (pace and sense) Sensed Refractory Period Test (SRP)   Range:  15 mS to 500 mS Accuracy:  ± 5 % of reading or ± 1 mS (whichever is greater) Physiological Simulation:  - Selection: Double pulse, R Wave, SSQ  - Pulse Width: 40 mS  - Amplitude: 1 mVpeak lead I Active Outputs:  5-lead ECG; ventricular test load Pacemaker Compatibility:  - Pulse Rates: 30 to 200 BPM  - Intended Type: VVI (pace and sense) Test Loads   Transcutaneous Pacer:  - Selections: (31) 50 Ω to 1550 Ω in 50-Ω steps  - Accuracy: ± 1 % of selection  - Power Rating: 5 W (average); 40 W (peak) @ 1000 Ω Input Defibrillation Protection:  - Type: Internal spark gap  Episode Limit: 5 pulses @ 360 J (10 seconds min between discharges)  - Life Limit: 250 pulses @ 360 J
Transvenous Pacer Tests:	Output Pulse Measurement   Current:  - Ranges: 0.05 mA to .999 mA (available single channel only); 1.00 mA to 9.99 mA; 10 mA to 30 mA  - Accuracy: ± 2 % of reading or ± 50 µA (whichever is greater)  - Polarity Indicator: + or - Rate:  - Ranges: 10.0 PPM to 99.9 PPM; 100 PPM to 999 PPM  - Accuracy: ± 0.5 % or 0.3 PPM (whichever is greater) Width:  - Ranges: 0.020 mS to .999 mS; 1.00 mS to 9.99 mS; 10.0 mS to 99.9 mS  - Accuracy: 0.5 % or ± 14 µS (whichever is greater)  - Resolution: ± 1 LSD or ± 4 µS (whichever is greater) Voltage:  - Ranges: (available single channel only) 0.050 Vpeak to .999 Vpeak; 1.00 Vpeak to 9.99 Vpeak; 10 Vpeak to 30 Vpeak  - Accuracy: ± 2 % of reading or ± 0.05 Vpeak (whichever is greater)  - Polarity Indicator: + or - Energy:  - Ranges: (available single channel only) 1 nJ to 999 nJ; 1 µJ to 999 µJ  - Accuracy: ± 5 % of reading/computation Display Formats:  Atrial channel only; ventricular channel only; both A + V channels AV Interval (Delay Time)   Measurement Ranges:  10.0 mS to 99.9 mS; 100 mS to 999 mS Start Point:  Atrial pulse leading edge Stop Point:  Ventricular pulse leading edge Accuracy:  1 % of reading/computation Demand/Async Mode Tests   Channels:  Single and dual Waveform:  Sine square (SSQ) Atrial Output:  Simulated P Wave  - Width: 30 mS  - Amplitude: 2.0 mVpeak Vent Output:  Simulated R Wave  - Width: 40 mS  - Amplitude: 2.5 mVpeak AV Interval:  90 mS (fixed) Interactive Simulated Rates:  - Default Settings: 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 Output:  Ventricular channel test load; atrial channel test load Pulse Rate:  30 to 200 PPM Intended Pacemaker Types:  - Demand: VVI (V-channel pace and sense); AAI (A-channel pace and sense); DDD (dual-channel pace and sense)  - Async/Continuous: VOO (V-channel pace and sense); AOO (A-channel pace and sense); DOO (dual-channel pace and sense) Amplitude Sensitivity Test   Operation:  Single-channel operation only (atrial or ventricular) Atrial Channel (Physiological Simulation):  - Selection: P Wave  - Rate: 30 to 120 BPM  - Timing: Waveform delayed by 80 % of the pulse-to-pulse interval or 400 mS (whichever is shorter)  - Active Output: Atrial test load Available Test Loads:  200 Ω, 500 Ω (default setting) and 1000 Ω ± 1 % Waveform Selections:  Square (SQU); triangle (TRI); haversine (HSN); sine square (SSQ) (default setting); asymmetrical triangle (ISO) – fixed width: 2 mS rise time/13 mS fall time Sensitivity Waveform Amplitude:   - Test Load Selection:  500 Ω (default setting)  -- Range: 0.05 mVpeak to 50.0 mVpeak  -- Accuracy: ± 5 % of setting  --Resolution: 0.05 mVpeak (0.05 to 0.95 mVpeak); 0.50 mVpeak (1 to 50 mVpeak) - Test Load Selection:  200 Ω  -- Range: 0.05 mVpeak to 20.0 mVpeak  -- Accuracy: ± 5 % of setting  -- Resolution: 0.05 mVpeak (0.05 to 0.95 mVpeak); 0.50 mVpeak (1 to 20 mVpeak) - Test Load Selection:  1000 Ω  -- Range: 0.05 mVpeak to 100 mVpeak-to-peak  -- Accuracy: ± 5 % of setting  -- Resolution: 0.05 mVpeak (0.05 to 0.95 mVpeak); 0.50 mVpeak (1.0 to 49.5 mVpeak); 05.0 mVpeak (50 to 100 mVpeak)  - Default Setting: 2.0 mVpeak Widths:  - Range: 0.15 mS to 95.0 mS  - Accuracy: ± 5 % of setting  - Resolution: 0.05 mS (0.15 mS to 0.95 mS); 1 mS (1 mS to 19 mS); 5 mS (20 mS to 95 mS) Intended Pacemaker Types:  AAI (atrial pace and sense)  - Pulse Rates: 30 to 200 PPM Ventricular Channel (Physiological Simulation):  - Selection: R Wave, S Wave and T Wave  - Rate: 30 to 120 BPM  - Timing: 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 Waveform Selections:  Square (SQU); triangle (TRI); haversine (HSN); sine square (SSQ) (default setting); asymmetrical triangle (ISO) – fixed width: 2 mS rise time/13 mS fall time Available Test Load(s):  200 Ω, 500 Ω (default setting) and 1000 Ω ± 1 % Amplitude:   - Pacer Load Selection:  500 Ω  -- Range: 0.05 to 50.0 mVpeak  -- Accuracy: ± 5 % of setting  -- Resolution: 0.05 mVpeak (0.05 to 0.95 mVpeak); 0.50 mVpeak (1 to 50 mVpeak) - Pacer Load Selection:  200 Ω  -- Range: 0.05 mVpeak to 20.0 mVpeak  -- Accuracy: ± 5 % of setting  -- Resolution: 0.05 mVpeak (0.05 to 0.95 mVpeak); 0.50 mVpeak (1 to 20 mVpeak) - Pacer Load Selection:  1000 Ω  -- Range: 0.05 mVpeak to 100 mVpeak-to-peak  -- Accuracy: ± 5 % of setting  -- Resolution: 0.05 mVpeak (0.05 to 0. 95 mVpeak); 0.50 mVpeak (1.0 to 49.5 mVpeak); 05.0 mVpeak (50 to 100 mVpeak)  - Default Setting: 2.5 mVpeak Widths:  - Range: 0.15 mS to 300 mS  - Accuracy: ± 5 % of setting  - Resolution: 0.05 mS (0.15 to 0.95 mS); 1 mS (1 to 19 mS); 5 mS (20 mS to 95 mS); 25 mS (100 mS to 300 mS) Intended Pacemaker Type(s):  VVI (atrial pace and sense only)  - Pulse Rates: 30 to 200 PPM Noise Immunity Test   Channels:  Single, atrial or ventricular only Waveform:  Sine wave Frequency:  50 and 60 Hz Accuracy:  ± 0.5 Hz Active Output(s):  Atrial- or ventricular-channel test load Output Selections:  Atrial channel only; ventricular channel only ECG Signal:  ECG signal can be added to the selected channel. Atrial:  1 mVpeak Ventricular:  1.5 mVpeak Noise Line Amplitude:   - Pacer Load Selection:  500 Ω  -- Range: 0 (OFF) to 100 mVpeak-to-peak  -- Accuracy: ± 5 % of setting  -- Resolution: 5-mVpeak-to-peak steps - Pacer Load Selection:  200 Ω  -- Range: 0 (OFF) to 40 mVpeak-to-peak  -- Accuracy: ± 5 % of setting  -- Resolution: 5-mVpeak-to-peak steps - Pacer Load Selection:  1000 Ω  -- Range: 0 (OFF) to 200 mVpeak-to-peak  -- Accuracy: ± 5 % of setting  -- Resolution: 5-mVpeak-to-peak steps Refractory Period Test (Atrial Channel)   Test Selections:  Paced refractory period; sensed refractory period Period:  20 to 500 mS Accuracy:  ± 5 % of reading (or ± 1 mS, whichever is greater) Resolution:  ± 1 LSD Physiological Simulation:  - Selection: Square wave (default setting)  - Atrial Channel: Simulated P Wave  - Width: 1 mS  - Amplitude: 20 mVpeak  - Active Outputs: Atrial channel (4mm banana jacks) only Additional Waveform Selections:  Square (SQU); triangle (TRI); haversine (HSN); sine square (SSQ); asymmetrical triangle (ISO) – fixed width: 2 mS rise time/13 mS fall time Amplitude:  - Range: .05 mVpeak to 50.0 mVpeak  - Accuracy: ± 5 % of setting  - Resolution: 0.05 mVpeak (0.05 to 0.95 mVpeak); 0.50 mVpeak (1.0 to 49.5 mVpeak ) Width:  - Range: 0.15 mS to 95.0 mS  - Accuracy: ± 5 % of setting  - Resolution: 0.05 mS (0.15 to 0.95 mS); 1 mS (1 to 19 mS); 5 mS (20 to 95 mS) Active Outputs:  Atrial channel (4mm banana jacks) only Intended Pacemaker Types:  AAI (atrial pace and sense only) Pacemaker Rates:  30 to 200 PPM Available Test Load:  500 Ω ± 1 % Refractory Period Test (Ventricular Channel)   Test Selections:  Paced refractory period; sensed refractory period Period:  20 to 500 mS Accuracy:  ± 5 % of reading (or ± 1 mS, whichever is greater) Resolution:  ± 1 LSD Display Format:  3 digits Physiological Simulation:  - Selection: Square wave (default setting)  - Ventricular Channel: Simulated R Wave  - Width: 1 mS  - Amplitude: 20 mVpeak  - Active Outputs: Ventricular channel (4mm banana jacks) only Additional Waveform Selections:  Square (SQU); triangle (TRI); haversine (HSN); sine square (SSQ); asymmetrical triangle (ISO) – fixed width: 2 mS rise time/13 mS fall time Amplitude:   - Pacer Load Selection:  500 Ω  -- Range: .05 mVpeak to 50.0 mVpeak  -- Accuracy: ± 5 % of setting  -- Resolution: 0.05 mVpeak (0.05 to 0.95 mVpeak); 0.50 mVpeak (1.0 to 49.5 mVpeak) - Default setting:  20 mVpeak Width:  - Range: 0.15 mS to 300.0 mS  - Accuracy: ± 5 % of setting  - Resolution: 0.05 mS (0.15 to 0.95 mS); 1 mS (1 to 19 mS); 5 mS (20 to 95 mS); 25 mS (100 to 300 mS)  - Default setting: 30 mS Intended Pacemaker Types:  VVI Pacemaker Rates:  20 to 200 PPM DC Leakage Current   Measurement Range:  00.1 µA to 99.9 µA Input Polarity:  Positive and negative Resolution:  1 LSD (0.1 µA) Display Format:  3 digits Test Selections:  - Static: Continuous (power OFF)  - Dynamic: Gated (power ON) Test Load/Input Configurations:  - Atrial+ and atrial-  - Ventricular+ and ventricular–  - Atrial+ and ventricular+ Baseline/Test Selection:  500 Ω Dynamic Test Gating Algorithm:  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 Specified Applied Pacemaker Rate:  80 PPM Current Drain Test   DC Current Ranges:  0.100 mA to 0.999 mA; 1.00 mA to 9.99 mA; 10.0 mA to 99.9 mA Polarity:  Positive or negative Indicator:  + or – symbol Resolution:  ± 1 LSD Display Format:  3 digits plus decimal point Accuracy:  ± 5 % of reading ± 10 µA Input DC Voltage:  - Nominal: ± 9 V  - Range: 5.0 V to 10.5 V  - Input Protection: Short-circuit protection  - Protection Type: Internal in-line fast-acting 1⁄2 A fuse Selectable Testloads:  200 Ω, 500 Ω, and 1000 Ω Battery Test Fixture:  9 V battery supply included, to facilitate connection of analyzer to recessed battery terminals within Medtronic 5388 and 5348 Temporary Pacemakers Test Loads   Atrial Channel:  - Selections: 200 Ω, 500 Ω, and 1000 Ω  - Accuracy: ± 1 % of selection  - Power Rating: 2 W Ventricular Channel:  - Selections: 200 Ω, 500 Ω, and 1000 Ω  - Accuracy: ± 1 % of selection  - Power Rating: 2 W Tracking:  Identical atrial and ventricular channel settings Input Defibrillation Protection:  - Type: Internal spark gap  - Episode Limit: 5 pulses @ 360 J (10 seconds min between discharges)  - Life Limit: 250 pulses @ 360 J Long-Term Test   Test Configuration:  - Transvenous Pacer: Atrial or ventricular channel only  - Transcutaneous Pacer: Ventricular channel  - Pulse Count Range: 999,999 (max)  - Rate: 2 % to 20 % (default setting, 10 %)  - Amplitude: 2 % to 20 % (default setting, 10 %)  - Test Time (max): 999:59:59 (hhh:mm:ss)  - Maximum Error Count: 200  - Test Termination: Manual; or upon max error count  - Testloads: 200 Ω, 500 Ω, and 1000 Ω Interactive Pacer ECG Simulation   Simulation of demand, continuous, noncapture, and nonfunction patient  -ECG activity Additional user   -selectable parameters:  - NSR Heart Rate: Asystole and 20 to 250 BPM (1-BPM steps)  - NSR PR Interval: 0.05 to 0.30 s (6 settings) Pacemaker Capture/Threshold:  - Transcutaneous: 10 to 250 mA (10-mA steps)  - Transvenous: 1 to 25 mA (1-mA steps) General Specifications   Serial Port:  - Type: RS232  - Connector Type: DB-9 (male)  - Baud Rates: 2400, 9600, and 19200  - Data Control: Xon/Xoff Power Requirements:  - External battery charger source/power supply  - 100 to 240 Vac, 50/60 Hz operation  - Auto power-off feature during battery operation Battery Life:  20 hours (min) Environmental Specifications   Temperature Range:  - Operating: 15 °C to 35 °C (59 °F to 95 °F)  - Storage: 0 °C to 50 °C (32 °F to 122 °F) Humidity Range:  < 90 % noncondensing Dimensions   Size:  8” L X 4” W X 2” H (approx) (203 mm L X 101 mm W X 50 mm H) Weight:  2 lb (approx) (0.90 kg) CE Mark   User Safety:   EMC:  EN61326-1.1997 Conforms to:  UL STD 3101-1 Certified to:  CAN/USA STD C22.2 No.1010 ETL Listed   Device has received FDA 510(k) clearance (on file)