Biomedicína

Fluke Bm. Sigma Pace 1000 - Analyzátor kardiostimulátorov

Fluke Bm. Sigma Pace 1000 - Analyzátor kardiostimulátorov

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.

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Dostupnosť: Na objednávku
 
Informácie
  • 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
SigmaPace™ 1000 External Pacemaker Analyzer
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)

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