| 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 |
| ETL Listed |
|
| Device has received FDA 510(k) clearance (on file) |
