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External Pacemakers
Medtronic external pacemakers are intended for use with a pacemaker lead system for temporary single or dual chamber pacing in a clinical environment.
Medtronic Single and Dual Chamber Temporary Pacemakers
Detail - Model 5348 Single Chamber Temporary Pacemaker
Detail - Model 5388 Dual Chamber Temporary Pacemaker
Model 5348
This single chamber temporary pacemaker is applicable when such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes:
- Rapid atrial pacing to manage atrial flutter
- Safety awareness ranges to alert clinician to areas of caution
- Sensitivity range (0.5 to 20 mV)
- Reversible battery polarity for quick battery changes
- Safe patient cable system for patient safety
Model 5388
The dual chamber model can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes:
- Just 3 dials provide simple and effective dual chamber temporary pacing
- Changing the pacing rate automatically adjusts other dual chamber temporary pacing parameters
- Additional therapy options are available
- The device paces up to 200 ppm
- Ventricular output to 25 mA for high stimulation thresholds
- Rapid atrial pacing rate up to 800 ppm for managing atrial tachyarrhythmias
Temporary Transvenous Pacing Lead – Model 6416
This temporary transvenous lead system features an active fixation, bipolar lead and a soft-tipped, lubricated guide catheter. The system is designed for temporary intracardiac pacing and/or EGM recording. It is disposable for single patient use with an intended implant duration of 7 days or less.
Important Safety Information
Changes in a patient's disease and/or medications may alter the efficacy of a device's programmed parameters or related features.
Specifications
Model 5348 Single Chamber Temporary Pacemaker
| Modes: | AAI, AOO, VVI, VOO |
|---|---|
| Rate: | 30-180 ppm, continuously adjustable |
| Rapid Atrial Pacing Rate | 80-380 ppm (5 ppm increments) 380-540 ppm (10 ppm increments) 540-800 ppm (20 ppm increments) |
| Output Amplitude | 0.1-20 mA, continuously adjustable |
| Pulse Width | 1.8 ms |
| Sensitivity | 0.5-20 mV, continuously adjustable, ASYNC |
| Refractory | 250 ms |
| Blanking | Pace: 125 ms Sense: 75 ms |
| Dimensions | 18.8 x 6.1 x 4.1 cm (7.4 x 2.4 x1.6 in.) 283 g (10 oz.) with battery |
| Battery Type | Standard 9 V, Alkaline or Lithium |
| Battery Life | Alkaline: 300 hours Lithium: 650 hours |
Model 5388 Dual Chamber Temporary Pacemaker
| Modes | DDD, DDI, DVI, DOO, AAI, AOO, VVI, VOO | |
|---|---|---|
| Base Pacing Rate | 30-200 ppm | |
| Upper Rate | 80-230 ppm | |
| Rapid Atrial Pacing Rate | 80-800 ppm | |
| Output Amplitude | Atrial: 0.1-20 mA | |
| Ventricular: 0.1-25 mA | ||
| Pulse Width | Atrial: 1.0 ms Ventricular: 1.5 ms | |
| Sensitivity | Atrial: 0.4-10 mV, async. Ventricular: 0.8-20 mV, async. | |
| A-V Interval | 20-300 ms | |
| Refractory Period | Atrial: 150-500 ms Ventricular: 250 ms | |
| Ventricular Blanking | Pace: 125 ms Sense: 75 ms | |
| Dimensions | 21.1 x 8.1 x 3.6 cm (8.3 x 3.2 x 1.4 in.) 510 g (18 oz.) with battery | |
| Battery Type | Standard 9 V, Alkaline or Lithium | |
| Battery Life | Alkaline: 9 days typical Lithium: 16 days typical | |
| Nominal | Emergency | |
| Mode | DDD | DOO |
| Rate | 80 ppm | 80 ppm or current setting |
| Output Amplitude Atrial Ventricular | 10 mA 10 mA | 20 mA 25 mA |
| Pulse Width Atrial Ventricular | 1.0 s 1.5 ms | 1.0 ms 1.5 ms |
| Sensitivity Atrial Ventricular | 0.5 mV 2.0 mV | async. Async. |
| A-V Interval Sensed Paced | 140 ms 170 ms | — 170 ms |
| PVARP | 300 ms | — |
| Upper Rate | 110 ppm | — |
| Rapid Atrial Pacing Rate | 320 ppm | — |
Model 6416 Temporary Transvenous Pacing Lead Specifications (Nominal)
| Parameter | Description |
|---|---|
| Polarity | Bipolar |
| Chamber | Atrium/Ventricle |
| Fixation | Active, screw-in |
| Lengths Lead Guide Catheter | 100, 140, 200 cm 40, 60, 90 cm |
| Diameters Lead Guide Catheter | 3.5 Fr. (1.1 mm, 0.044 in.) 6 Fr. outer 5 Fr. inner |
| Helix Design Length Diameter | Two right turns 0.8 mm (0.032 in.) 0.9 mm (0.035 in.) |
| Tip Electrode (includes helix) Surface Area | 4.3 mm2 |
| Ring Electrode Surface Area | 17 mm2 |
| Tip-Ring Spacing Connector | 1 cm (0.39 in.) Bifurcated, pull-through short arm = positive long arm = negative |
| Lead Material | |
| Conductor: | Stainless steel |
| Insulation: | Polyethylene and FEP |
| Helix: | Stainless steel |
| Catheter Material | Pebax® |
| Lead Resistance | |
| 100-cm lead Inner wire (tip) Outer wire (ring) | 55 Ω maximum 33 maximum |
| 140-cm lead Inner wire (tip) Outer wire (ring) | 75 Ω maximum 45 Ω maximum |
| 200-cm lead Inner wire (tip) Outer wire (ring) | 105 Ω maximum 63 Ω maximum |
| Recommended revolutions to extend helix: 100-cm lead 14-cm lead 200-cm lead | 2-3 revolutions 3-4 revolutions 4-5 revolutions |
| Model Number | Guide Catheter French Size (Fr) | Guide Catheter Length (cm) | Lead French Size (Fr) | Lead Length (cm) | Tip Electrode (mm2) |
|---|---|---|---|---|---|
| Single Pack | |||||
| 6416100S | 6 | 40 | 3.5 | 100 | 4.3 |
| 6416140S | 6 | 60 | 3.5 | 140 | 4.3 |
| 6416200S | 6 | 90 | 3.5 | 200 | 4.3 |
| Five Pack | |||||
| 6416100 | 6 | 40 | 3.5 | 100 | 4.3 |
| 6416140 | 6 | 60 | 3.5 | 140 | 4.3 |
| 6416200 | 6 | 90 | 3.5 | 200 | 4.3 |
Last updated: 26 Feb 2013