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SigmaPace 1000 external pacemaker analyzer

Sigma Pace 1000 Pacemaker Analyzer

SigmaPace 1000 External Pacemaker Analyzer

The SigmaPace™ 1000 is a powerful handheld tool 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.

*not available in Europe

Standard Features

  • 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 ? to 1550 ? in 50-? 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 ? to 1550 ? ± 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 ? to 1550 ? in 50-? steps
Accuracy: ± 1 % of selection
Power Rating: 5 W (average); 40 W (peak) @ 1000 ?
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 ?, 500 ? (default setting) and 1000 ? ± 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 ? (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 ?
-- 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 ?
-- 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 ?, 500 ? (default setting) and 1000 ? ± 1 %
Amplitude:
- Pacer Load Selection: 500 ?
-- 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 ?
-- 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 ?
-- 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 ?
-- Range: 0 (OFF) to 100 mVpeak-to-peak
-- Accuracy: ± 5 % of setting
-- Resolution: 5-mVpeak-to-peak steps
- Pacer Load Selection: 200 ?
-- Range: 0 (OFF) to 40 mVpeak-to-peak
-- Accuracy: ± 5 % of setting
-- Resolution: 5-mVpeak-to-peak steps
- Pacer Load Selection: 1000 ?
-- 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 ? ± 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 ?
-- 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 ?
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 ?, 500 ?, and 1000 ?
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 ?, 500 ?, and 1000 ?
Accuracy: ± 1 % of selection
Power Rating: 2 W
Ventricular Channel: Selections: 200 ?, 500 ?, and 1000 ?
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 ?, 500 ?, and 1000 ?
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
Model NameDescription
SIGMAP1K-USA120VSigmapace 1000 External Pacemaker Analyzer Tests both transcutaneous & transvenous external pacemakers, USA, 120 V (Item #2247700)

Includes:

  • Operator's manual (Item #2243306)
  • Nylon carrying case (Item #2392906)
  • Transvenous pacer test leads 2 sets (2 each red leads (Item #2201166), and black leads (Item #2201153))
  • SigmaPace 9 V dc load test cable (Item #2392272)
  • Serial interface cable (Item #2392260)
  • Universal-input battery charger (Item #2184298)
  • Power cord set USA 120 V ac
SIGMAP1K-JPN100VSigmapace 1000, Japan, 100 V (Item #2394548)

Includes:

  • Operator's manual (Item #2243306)
  • Nylon carrying case (Item #2392906)
  • Transvenous pacer test leads, 2 sets (2 each red leads (Item #2201166), and black leads (Item #2201153))
  • SigmaPace 9 V dc load test cable (Item #2392272)
  • Serial interface cable (Item #2392260)
  • Universal-input battery charger (Item #2184298)
  • Power cord set USA 120 V ac
SIGMAP1K-SHK250VSigmapace 1000, Schuko, 250 V (Item #2394553)

Includes:

  • Operator's manual (Item #2243306)
  • Nylon carrying case (Item #2392906)
  • Transvenous pacer test leads, 2 sets (2 each red leads (Item #2201166), and black leads (Item #2201153))
  • SigmaPace 9 V dc load test cable (Item #2392272)
  • Serial interface cable (Item #2392260)
  • Universal-input battery charger (Item #2184298)
  • Power cord set USA 120 V ac
SIGMAP1K-UK250VSigmapace 1000, United Kingdom, 250 V (Item #2394566)
Includes:
  • Operator's manual (Item #2243306)
  • Nylon carrying case (Item #2392906)
  • Transvenous pacer test leads, 2 sets (2 each red leads (Item #2201166), and black leads (Item #2201153))
  • SigmaPace 9 V dc load test cable (Item #2392272)
  • Serial interface cable (Item #2392260)
  • Universal-input battery charger (Item #2184298)
  • Power cord set USA 120 V ac

Test Leads, Probes and Clips
3010-06103010-0610 SGMA TV test lead - black
(part# 2201153) for SigmaPace 1000
Used for testing invasive pacemakers. Two (2) required for dual chamber testing.
3010-06113010-0611 SGMA TV test lead - red
(part# 2201166) for SigmaPace 1000
Used for testing invasive pacemakers. Two (2) required for dual chamber testing.

Combination Defibrillator and Pacer Adapters
3010-06093010-0609, Zoll PD & M-Series adapter (part# 2201148)
(for use with SigmaPace 1000)

Pacer Adapters
3010-06033010-0603 Physio Quik Pace (part# 2201088)
(for use with SigmaPace 1000)
3010-06043010-0604 Physio Quik Combo (part# 2201095)
(for use with SigmaPace 1000)
3010-06053010-0605 Agilent HP CodeMaster adapter (part# 2201109)
(for use with SigmaPace 1000)
3010-06063010-0606 MQ Responder (part# 2201111)
GE Marquette Medical electrode adapter (for use with SigmaPace 1000)
3010-06083010-0608, Zoll NTP adapter (part# 2201130)
(for use with SigmaPace 1000)

Batteries, Chargers, and Power Supply
3010-0655Detachable AC power cord set (UK) (part# 2201428)
IEC 320 C6 type 3-pin inlet (for SigmaPace 1000)
9513-02029513-0202 Adapter Kit-4.0MM To Snap (part# 2245006)
(for use with SigmaPace 1000)
3010-0654IEC 320 C6 type 3-pin AC power cord set (part# 2201419)
for ProSim 8 or SigmaPace 1000 (Japan)
Sigma1K-8001Sigma1K-8001 SigmaPace 1000 battery pack
(part# 2229830)

Cables
3010-0585FGSerial Interface Cable, DB9F to DB9F (PC to SigmaPace™1000) (part#2392260) (this requires F-M gender changer)
3010-0602FG3010-0602FG, 9VDC Load Test Cable (part# 2392272)
(for use with SigmaPace 1000)
3010-06393010-0639 Philips Agilent Cable (part# 2201323)
(for use with SigmaPace 1000)

Service Packages
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