SigmaPaceTM 1000 External Pacemaker Analyser

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.

Categories: Defibrillator Analysers, Fluke Biomedical

SigmaPace 1000 External Pacemaker Analyzer

*not available in Europe

Features

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

Models and Accessories

Model Name

Description

SIGMAP1K-USA120V

Sigmapace 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-JPN100V

Sigmapace 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-SHK250V

Sigmapace 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-UK250V

Sigmapace 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
3010-0610	3010-0610 SGMA TV test lead – black (part# 2201153) for SigmaPace 1000 Used for testing invasive pacemakers. Two (2) required for dual chamber testing.
3010-0611	3010-0611 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
3010-0609	3010-0609, Zoll PD & M-Series adapter (part# 2201148) (for use with SigmaPace 1000)

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

Batteries, Chargers, and Power Supply
3010-0655	Detachable AC power cord set (UK) (part# 2201428) IEC 320 C6 type 3-pin inlet (for SigmaPace 1000)
3010-0654	IEC 320 C6 type 3-pin AC power cord set (part# 2201419) for ProSim 8 or SigmaPace 1000 (Japan)
Sigma1K-8001	Sigma1K-8001 SigmaPace 1000 battery pack (part# 2229830)

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

Service Packages
Care Plans	Request a quote

SigmaPaceTM 1000 External Pacemaker Analyser

SigmaPace 1000 External Pacemaker Analyzer

Features

Specifications

Models and Accessories

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