Output Pulse Measurement |
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Current: |
- Ranges: 0.05 mA to .999 mA (available single channel only); 1.00 mA to 9.99 mA; 10 mA to 30 mA |
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- Accuracy: ± 2 % of reading or ± 50 µA (whichever is greater) |
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- Polarity Indicator: + or - |
Rate: |
- Ranges: 10.0 PPM to 99.9 PPM; 100 PPM to 999 PPM |
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- 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 |
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- Accuracy: 0.5 % or ± 14 µS (whichever is greater) |
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- 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 |
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- Accuracy: ± 2 % of reading or ± 0.05 Vpeak (whichever is greater) |
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- Polarity Indicator: + or - |
Energy: |
- Ranges: (available single channel only) 1 nJ to 999 nJ; 1 µJ to 999 µJ |
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- Accuracy: ± 5 % of reading/computation |
Display Formats: |
Atrial channel only; ventricular channel only; both A + V channels |
AV Interval (Delay Time) |
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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 |
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Channels: |
Single and dual |
Waveform: |
Sine square (SSQ) |
Atrial Output: |
Simulated P Wave |
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- Width: 30 mS |
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- Amplitude: 2.0 mVpeak |
Vent Output: |
Simulated R Wave |
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- Width: 40 mS |
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- 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 |
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- Manual: NSR simulations adjustable in 1-BPM increments |
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- 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 |
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Operation: |
Single-channel operation only (atrial or ventricular) |
Atrial Channel (Physiological Simulation): |
- Selection: P Wave |
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- Rate: 30 to 120 BPM |
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- Timing: Waveform delayed by 80 % of the pulse-to-pulse interval or 400 mS (whichever is shorter) |
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- 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: |
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- Test Load Selection: |
500 Ω (default setting) |
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-- Range: 0.05 mVpeak to 50.0 mVpeak |
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-- Accuracy: ± 5 % of setting |
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--Resolution: 0.05 mVpeak (0.05 to 0.95 mVpeak); 0.50 mVpeak (1 to 50 mVpeak) |
- Test Load Selection: |
200 Ω |
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-- Range: 0.05 mVpeak to 20.0 mVpeak |
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-- Accuracy: ± 5 % of setting |
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-- Resolution: 0.05 mVpeak (0.05 to 0.95 mVpeak); 0.50 mVpeak (1 to 20 mVpeak) |
- Test Load Selection: |
1000 Ω |
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-- Range: 0.05 mVpeak to 100 mVpeak-to-peak |
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-- Accuracy: ± 5 % of setting |
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-- 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) |
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- Default Setting: 2.0 mVpeak |
Widths: |
- Range: 0.15 mS to 95.0 mS |
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- Accuracy: ± 5 % of setting |
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- 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) |
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- Pulse Rates: 30 to 200 PPM |
Ventricular Channel (Physiological Simulation): |
- Selection: R Wave, S Wave and T Wave |
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- Rate: 30 to 120 BPM |
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- Timing: Waveform delayed from the ventricular demand pacemaker pulse by 80 % of the pulse-to-pulse interval or 400 mS (whichever is shorter) |
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- 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: |
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- Pacer Load Selection: |
500 Ω |
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-- Range: 0.05 to 50.0 mVpeak |
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-- Accuracy: ± 5 % of setting |
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-- Resolution: 0.05 mVpeak (0.05 to 0.95 mVpeak); 0.50 mVpeak (1 to 50 mVpeak) |
- Pacer Load Selection: |
200 Ω |
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-- Range: 0.05 mVpeak to 20.0 mVpeak |
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-- Accuracy: ± 5 % of setting |
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-- Resolution: 0.05 mVpeak (0.05 to 0.95 mVpeak); 0.50 mVpeak (1 to 20 mVpeak) |
- Pacer Load Selection: |
1000 Ω |
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-- Range: 0.05 mVpeak to 100 mVpeak-to-peak |
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-- Accuracy: ± 5 % of setting |
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-- 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) |
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- Default Setting: 2.5 mVpeak |
Widths: |
- Range: 0.15 mS to 300 mS |
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- Accuracy: ± 5 % of setting |
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- 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) |
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- Pulse Rates: 30 to 200 PPM |
Noise Immunity Test |
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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: |
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- Pacer Load Selection: |
500 Ω |
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-- Range: 0 (OFF) to 100 mVpeak-to-peak |
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-- Accuracy: ± 5 % of setting |
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-- Resolution: 5-mVpeak-to-peak steps |
- Pacer Load Selection: |
200 Ω |
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-- Range: 0 (OFF) to 40 mVpeak-to-peak |
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-- Accuracy: ± 5 % of setting |
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-- Resolution: 5-mVpeak-to-peak steps |
- Pacer Load Selection: |
1000 Ω |
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-- Range: 0 (OFF) to 200 mVpeak-to-peak |
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-- Accuracy: ± 5 % of setting |
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-- Resolution: 5-mVpeak-to-peak steps |
Refractory Period Test (Atrial Channel) |
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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) |
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- Atrial Channel: Simulated P Wave |
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- Width: 1 mS |
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- Amplitude: 20 mVpeak |
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- 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 |
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- Accuracy: ± 5 % of setting |
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- 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 |
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- Accuracy: ± 5 % of setting |
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- 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) |
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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) |
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- Ventricular Channel: Simulated R Wave |
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- Width: 1 mS |
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- Amplitude: 20 mVpeak |
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- 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: |
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- Pacer Load Selection: |
500 Ω |
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-- Range: .05 mVpeak to 50.0 mVpeak |
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-- Accuracy: ± 5 % of setting |
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-- 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 |
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- Accuracy: ± 5 % of setting |
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- 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) |
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- Default setting: 30 mS |
Intended Pacemaker Types: |
VVI |
Pacemaker Rates: |
20 to 200 PPM |
DC Leakage Current |
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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) |
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- Dynamic: Gated (power ON) |
Test Load/Input Configurations: |
- Atrial+ and atrial- |
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- Ventricular+ and ventricular– |
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- 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 |
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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 |
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- Range: 5.0 V to 10.5 V |
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- Input Protection: Short-circuit protection |
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- 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 |
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Atrial Channel: |
- Selections: 200 Ω, 500 Ω, and 1000 Ω |
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- Accuracy: ± 1 % of selection |
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- Power Rating: 2 W |
Ventricular Channel: |
- Selections: 200 Ω, 500 Ω, and 1000 Ω |
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- Accuracy: ± 1 % of selection |
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- Power Rating: 2 W |
Tracking: |
Identical atrial and ventricular channel settings |
Input Defibrillation Protection: |
- Type: Internal spark gap |
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- Episode Limit: 5 pulses @ 360 J (10 seconds min between discharges) |
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- Life Limit: 250 pulses @ 360 J |
Long-Term Test |
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Test Configuration: |
- Transvenous Pacer: Atrial or ventricular channel only |
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- Transcutaneous Pacer: Ventricular channel |
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- Pulse Count Range: 999,999 (max) |
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- Rate: 2 % to 20 % (default setting, 10 %) |
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- Amplitude: 2 % to 20 % (default setting, 10 %) |
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- Test Time (max): 999:59:59 (hhh:mm:ss) |
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- Maximum Error Count: 200 |
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- Test Termination: Manual; or upon max error count |
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- Testloads: 200 Ω, 500 Ω, and 1000 Ω |
Interactive Pacer ECG Simulation |
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Simulation of demand, continuous, noncapture, and nonfunction patient |
-ECG activity |
Additional user |
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-selectable parameters: |
- NSR Heart Rate: Asystole and 20 to 250 BPM (1-BPM steps) |
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- NSR PR Interval: 0.05 to 0.30 s (6 settings) |
Pacemaker Capture/Threshold: |
- Transcutaneous: 10 to 250 mA (10-mA steps) |
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- Transvenous: 1 to 25 mA (1-mA steps) |
General Specifications |
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Serial Port: |
- Type: RS232 |
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- Connector Type: DB-9 (male) |
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- Baud Rates: 2400, 9600, and 19200 |
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- Data Control: Xon/Xoff |
Power Requirements: |
- External battery charger source/power supply |
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- 100 to 240 Vac, 50/60 Hz operation |
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- Auto power-off feature during battery operation |
Battery Life: |
20 hours (min) |
Environmental Specifications |
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Temperature Range: |
- Operating: 15 °C to 35 °C (59 °F to 95 °F) |
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- Storage: 0 °C to 50 °C (32 °F to 122 °F) |
Humidity Range: |
< 90 % noncondensing |
Dimensions |
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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 |
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User Safety: |
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EMC: |
EN61326-1.1997 |
Conforms to: |
UL STD 3101-1 |
Certified to: |
CAN/USA STD C22.2 No.1010 |
ETL Listed |
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Device has received FDA 510(k) clearance (on file) |
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