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General| Brand | Medtronic |
|---|---|
| Model | 5348 |
| Category | Medical Equipment |
| Language | English |
Lists the items supplied with the Model 5348, including battery, literature, pouch, and cables.
Lists safety features such as self-tests, low battery indicator, and runaway rate protection.
Instructions for completing and returning the registration card.
Refers to accompanying documents for complete device warranty and disclaimer.
Single chamber atrial pacing is contraindicated in the presence of AV conduction disorders.
Asynchronous pacing is contraindicated in the presence of intrinsic cardiac rhythms.
High-rate burst therapy is intended for use in the atrium only; use in the ventricle can cause life-threatening arrhythmias.
Do not modify the equipment; modifications can impact effectiveness and patient safety.
Caution must be taken with line-powered equipment due to fibrillation danger from current leakage.
Electrosurgery can induce ventricular fibrillation and should not be used near implanted lead systems.
Pacemakers are sensitive to external fields; strong EMI may cause inhibition or reversion to asynchronous mode.
While the device is not affected by 360 Ws discharges, avoid placing paddles near the pacemaker or lead system.
High rates in the atrium can lead to ventricular conduction; have defibrillation equipment ready.
The patient cable should be connected to the pacemaker before the lead system is connected to the patient.
Avoid touching terminal pins or exposed metal of indwelling leads; prevent contact with conductive or wet surfaces.
All patient, lead, cable, and device connections must be made before powering on the pacemaker.
The pacemaker may fail due to component failure, battery depletion, or mishandling; possible malfunctions are listed.
Improper connection, displacement, or fracture of leads or cables can lead to system failure.
During adjustments, stimuli may be delivered into a vulnerable period; monitor ECG and keep defibrillation equipment ready.
Bipolar lead systems are recommended due to less susceptibility to EMI; specific connection instructions for unipolar systems are provided.
Setting sensitivity too low can lead to inappropriate sensing of far-field signals, inhibiting pacing.
Discharge personal static electricity before touching the patient, cable, leads, or pacemaker due to the low-impedance pathway to the heart.
Abrupt termination may cause asystole; gradual reduction in pacing rate is recommended.
Replace battery for each new patient and when low battery indicator appears; check status twice daily.
Do not place the device where patients may interact with it to minimize tampering by unauthorized personnel.
Do not drop, mishandle, or spill fluid on the unit; use a protective pouch to prevent fluid incursion.
Always use safe ESD procedures as the device can be adversely affected by ESD.
Do not open the device; do not sterilize by gamma irradiation or steam sterilization.
Rapid temperature changes and prolonged high humidity can affect operation; allow device to dry.
Adverse effects include asystole after cessation, inhibition/reversion due to EMI, and tachyarrhythmia initiation.
High-rate pacing may cause tachycardia, acceleration, or fibrillation; monitor ECG and have defibrillation equipment ready.
Adverse effects include inappropriate connections, disconnections, lead fracture, myocardial irritability, perforation, and infarction.
Other effects include body rejection, muscle/nerve stimulation, and infection.
Describes the dials and keys for controlling Rate, Output, and Sensitivity.
The device is turned on by pressing the ON key; turned off by pressing ON and OFF keys simultaneously.
Controls for enabling/disabling RAP, setting rate, and delivering bursts.
LEDs providing feedback on device operation like pacing, sensing, and battery status.
Illustrates and labels controls, indicators, and physical features of the device.
Located at the top, accepts safety cables and heartwires; includes openings for direct connection of heartwires.
Typical battery life for alkaline and lithium batteries under specific conditions.
Device continues to operate for at least 15 seconds when battery is removed.
Located on the back for attaching to IV pole or securing the device during transit.
Device performs a self-test upon power-on to check keys, battery, and internal components.
Device monitors RAP feature use and automatically disables standby after 5 minutes of inactivity.
Monitors crystal rate and restarts the system or turns off the device if deviation occurs.
The pacing pulse width is fixed at 1.8 ms.
Provides demand pacing, inhibiting output when intrinsic activity is sensed.
Provides fixed-rate pacing; sensing circuitry is turned off.
Period after paced/sensed event when sense amplifier is disabled.
Period during which a sensed event does not restart the escape interval.
Prevents loss of pacing therapy during continuous EMI by reverting to asynchronous mode.
Designed to connect leads to the Model 5348 for temporary pacing; they are reusable and supplied non-sterile.
Designed to connect cardiac pacing leads to the Model 5348; they are safety cables.
Designed to protect and hold the Model 5348 Pacemaker; should be disposed of after each use.
Instructions for inserting the pacemaker into the pouch and securing it.
Instructions for replacing the 9-volt battery, including recommended types and precautions.
Steps for connecting the patient cable to the pacemaker, including warnings and notes.
Instructions for connecting pacing leads to the patient cable, including inspection and caution.
Instructions for direct connection of heartwires/leads in emergency situations, with warnings.
Cautions regarding secure connection, exposed pins, and contact with surfaces.
Steps to power the device on and off, with cautions regarding battery and initial operation.
Describes the self-test initiated upon device power-on and indicator behavior.
Outlines basic pacing operations in demand and asynchronous modes.
Explains how lead placement and sensitivity setting determine demand or asynchronous mode.
Details how to adjust Rate, Output, and Sensitivity parameters.
Step-by-step guide to determine sensing thresholds for proper demand pacing.
Step-by-step guide to determine stimulation thresholds for appropriate output settings.
Detailed steps for using the Rapid Atrial Pacing feature.
Ensure leads are in contact with the atrium before enabling RAP Standby.
Flip cover and press ENABLE/DISABLE key to activate RAP controls and display nominal rate.
Use ^ and v keys to increase or decrease the RAP rate.
Press and hold HOLD TO DELIVER key to deliver pacing pulses asynchronously at the selected rate.
RATE and OUTPUT can be adjusted during RAP delivery; SENSITIVITY has no effect.
Release HOLD TO DELIVER to resume basic pacing; press ENABLE/DISABLE to disable RAP Standby.
Procedures for cleaning and disinfecting the pacemaker and patient cables.
Outlines checks to be performed periodically and after malfunctions.
Inspect technical manual inscriptions, warning signs, mechanical damage, and battery compartment.
Check self-test, front panel controls, connections, and warnings.
Includes tests for Rate, RAP, Pulse Width, Output, Sensitivity, Frequency Response, and Refractory Period.
Medtronic does not recommend field repair; contact local representative for service or repair.
Synchronous (AAI/VVI) and asynchronous (AOO/VOO) modes.
Adjustable rate range from 30 to 180 ppm.
Rates for RAP vary from 80 to 800 ppm with different increment steps.
Adjustable output from 0.1 to 20 mA.
The pacing pulse width is fixed at 1.8 ms.
Adjustable from ASYNC. to 20 mV, including polarity considerations.
Refractory period is 250 ms ± 5%.
Pace blanking is 125 ms, Sense blanking is 75 ms.
Crystal-based rate setting with rate runaway protection circuit.
10°C to 43°C (50°F to 110°F).
-40°C to 70°C (-40°F to 158°F) without battery.
90% maximum.
Standard 9V alkaline or lithium batteries.
Typical battery life for alkaline and lithium batteries under specific conditions.
Minimum operation time after battery removal before shut-off.
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