medtronic
Model 5388 Dual Chamber Temporary Pacemaker Technical Manual
148 Pages

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5388
Dual Chamber Temporary Pacemaker
Technical Manual c Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
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MODEL 5388 Technical Manual
Dual Chamber Temporary Pacemaker
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0
Symbols
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Explanation of symbols Consult instructions for use
Type CF applied part
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Conformité Européenne (European Conformity) This symbol means that the device fully complies with European Directive 93/42/EEC . Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product.
For US audiences only
Package contents
Temporary pacemaker
Product documentation
Accessories
Storage temperature limitation
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Explanation of symbols Humitidy limitation
Battery
Reorder number
Authorized representative in the European Community
EC REP Manufacturer
Date of manufacture
Serial number
5388 Technical manual
Contents 1
Overview
9
General Description Intended Use
12
Contraindications 2
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12
Warnings, precautions, and adverse effects 15 Warnings
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Precautions
18
Environmental Precautions Adverse Effects 3
23
Controls, indicators, and other features Controls
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Light-Emitting Diodes Upper Screen
33
Lower Screen
37
Physical Features
32
46
Functional Features Timing Violations 4
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49
53
Preparation for use 57 Battery Installation
58
Disposable Pouch
59
Disposable Cover
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Cables
60
Connector Setup 61 5
User guide
67
Overview
68
Indicators
69
Basic Operation
70
Connector Setup 77 Pacing Parameter Adjustments Thresholds
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83
Pacing Setup 88 5388 Technical manual
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Contents
RAP (Rapid Atrial Pacing) Battery Replacement Tables 6
90
92
94
Device maintenance
97
Cleaning and Sterilization
98
Safety and Technical Checks Service 7
100
Specifications
101
Device Specifications Device Accessories 8
99
102 105
Warranty information Special Notices
107
108
A Pacemaker diagnostic diagrams 109 About the Chapter Definitions
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110
Single Chamber Modes Dual Chamber Modes Index
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113 118
Overview General Description 10 Intended Use 12 Contraindications
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Chapter 1 General Description
General Description The Medtronic® Model 5388 is a battery-powered, temporary, dual chamber pacemaker designed primarily for temporary antibradycardia pacing therapy. The device provides eight selectable modes of pacing therapy: DDD, DVI, DDI, DOO, VOO, VVI, AOO, and AAI. High-rate, burst pacing therapy up to 800 min-1 (reciprocal minutes), for atrial tachyarrhythmias, is 1 available in the asynchronous mode.
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The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using patient cables (Medtronic Models 5433A and 5433V) or surgical cables (Medtronic Model 5832 or 5832S).
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Figure 1-1. The Medtronic Model 5388 Dual Chamber Temporary Pacemaker and the Model 5433A or 5433V Patient Cable.
The device operates using a 9-volt alkaline or lithium battery, installed in the battery drawer at the lower right side of the device. Note: The Model 5388 is a constant current device. When it emits a pulse, the current output is maintained at a constant value. This value is set by the output control and does not vary.
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5388 Technical manual
For atrial use only.
Overview General Description
Safety Features The Medtronic Model 5388 is designed to be reliable, easy to operate, and comfortable to hold. Safety features of the Model 5388 include: ■
Cables with no exposed electrical connections;
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Self-test function;
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Low Battery indicator;
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Lock feature to prevent accidental change of parameters;
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Safe, two-step operation to turn the device off;
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Runaway rate protection;
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Protection from defibrillation shock;
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Continuous operation during battery replacement (see page 105);
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Reversible battery polarity;
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Electrostatic protection;
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Minimized susceptibility to electromagnetic and magnetic interference; and
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Rubber seals to cover the connector pin receptacles.
Package Contents See the enclosed card for a detailed list of package contents. Check the package prior to use. Damaged packages should be returned to Medtronic (see back cover for address).
Registration Card Please complete the registration card and return it to Medtronic. Consult the back cover of this manual for the address.
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Chapter 1 Intended Use
Intended Use The Medtronic Model 5388 temporary pacemaker is intended to be used in conjunction with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The Model 5388 can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes. Specific indications for temporary cardiac pacing include, but are not limited to, the following: ■
Complete heart block;
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Sinus bradycardia;
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Sick sinus syndrome;
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Bradycardia with congestive heart failure;
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Atrial and/or ventricular arrhythmias;
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Cardiac arrest;
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Support, management, and evaluation of a patient prior to permanent pacemaker implantation;
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Support during permanent pacemaker replacement;
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Cardiac complications during invasive or surgical procedures;
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Support following cardiac surgery;
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Acute myocardial infarction complicated by heart block; and
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High-rate burst pacing for treatment of atrial tachyarrhythmias.
The Model 5388 can be used to determine sensing thresholds of temporary and permanently implanted lead systems. When implanting a permanent pacemaker, however, Medtronic recommends the use of a Medtronic Pacing System Analyzer.
Contraindications There are no known contraindications to the use of temporary pacing as a means to control the heart rate. The patient’s age and medical condition, however, may dictate the type of temporary pacemaker and lead system used by the physician.
5388 Technical manual
Overview Contraindications
Atrial Sensing Pacing modes which allow sensing in the atrium to trigger a ventricular response are contraindicated in the presence of rapid atrial arrhythmias such as atrial fibrillation or atrial flutter.
Atrial Pacing Atrial pacing is ineffective in the presence of atrial fibrillation or flutter. Single chamber atrial pacing is contraindicated in the presence of AV conduction disorders.
Asynchronous Pacing Asynchronous pacing is contraindicated in the presence of intrinsic cardiac rhythms.
Atrial High-Rate Burst Pacing Therapy Atrial high-rate burst pacing therapy is intended for use in the atrium only. High-rate burst pacing in the ventricle may result in life-threatening arrhythmias.
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Warnings, precautions, and adverse effects
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Warnings
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Precautions
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Environmental Precautions Adverse Effects
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Chapter 2 Warnings
Warnings Equipment Modification Do not modify this equipment. Modifications could impact device effectiveness and adversely affect patient safety.
Defibrillation/Cardioversion Defibrillation discharges up to 360 watt-seconds have not affected the Model 5388 in laboratory tests. However, for maximum safety, it is recommended that paddles be placed at least 15 cm (6 inches) away from the Model 5388 or the lead system. Whenever possible, for the safety of the patient, disconnect the pacemaker from the lead system before defibrillating or cardioverting. A relatively low resistance pathway exists between the positive (+) and negative (–) electrodes of the implanted lead system. During defibrillation a large current could flow across this pathway, causing myocardial damage.
Line-powered Equipment An implanted lead or lead with extension cable constitutes a direct, low-resistance current pathway to the myocardium. Due to the danger of tachyarrhythmias resulting from alternating current leakage, extreme caution must be taken to properly ground all line-powered equipment used on or in the vicinity of the patient.
Electrosurgical Units (Cautery) Electrosurgical units can cause tachyarrhythmias by inducing current on the leads, and thus should never be used within 15 cm (6 inches) of the pacemaker/lead system.
Electromagnetic Interference (EMI) Pacemakers operating in the demand mode respond to intracardiac potentials with magnitudes of a few millivolts. This level of sensitivity makes the pacemaker inherently sensitive to some external fields. In the presence of excessive levels of interference, the Model 5388 may inhibit completely or revert to asynchronous operation, pacing at the rate set by the RATE dial.
5388 Technical manual
Warnings, precautions, and adverse effects Warnings It is recommended that the device be set to an asynchronous mode at a rate higher than the patient’s intrinsic rate when operated in the presence of strong electromagnetic interference (EMI). Sources of excessively strong EMI which may temporarily affect the operation of the Model 5388 include: ■
Electrosurgical equipment;
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Diathermy equipment;
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Some medical telemetry equipment [when operated within one meter (about three feet) of the pacemaker];
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Communication transmitters such as cellular phones, “walkie talkies”, and transmitters in emergency transport vehicles; and
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Magnetic Resonance Imaging (MRI) equipment.
Atrial High-Rate Burst Pacing Therapy Use of high rates in the atrium could result in high-rate conduction to the ventricle. Defibrillation equipment should be on standby, immediately available during atrial high-rate burst pacing therapy. There is no ventricular back-up pacing during delivery of atrial high-rate burst pacing therapy.
Connecting the Lead System The patient cable should be connected to the temporary pacemaker before the lead(s) is connected to the patient cable(s). To prevent pacing into the vulnerable period of the T-wave, turn the temporary pacemaker ON and turn A and V OUTPUT down to the minimum amplitude before connecting the temporary pacemaker to the patient’s lead system. Determine sensing thresholds (see “Sensing Threshold” on page 84) before turning A and V OUTPUT up to threshold levels.
Handling Implanted Leads When handling implanted leads (temporary or permanent), the terminal pins or exposed metal must not be touched nor be allowed to contact electrically conductive or wet surfaces.
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Chapter 2 Precautions
Precautions Random Failures The physician should be aware that operational failure of the Model 5388 temporary pacemaker can occur as the result of battery depletion, mishandling, or random component failure. Possible operational failures of the Model 5388 can include: ■
No output or erratic output;
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No sensing or erratic sensing;
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False indicator light signals;
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Inappropriate variance of rate, output pulse width, or output amplitude;
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Reversion to asynchronous pacing; and
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Loss of control of rate, output, sensitivity or power.
If loss of control of rate, output, sensitivity or power occurs, and it is not due to a low battery, disconnect the device from the patient and return it to Medtronic for service.
Batteries Use of batteries with different physical dimensions from that of the recommended batteries may result in erratic, or no, pacing output. Replace the battery for each new patient, and when the low battery indicator appears during device operation (see page 33). Check the battery status at least twice daily. Replace alkaline batteries at least once every week when the temporary pacemaker is in continuous use or when the low battery indicator is displayed. When replacing the battery, make sure the battery drawer is fully closed and latches in place with an audible click. Inspect the contacts on the battery for visible signs of contamination prior to use. Use of batteries with contamination on the contacts may result in erratic, or no output. Failure to ensure that the battery drawer is fully latched may result in a loss of power. Continued device operation is NOT an indication that the battery drawer is properly latched.
5388 Technical manual
Warnings, precautions, and adverse effects Precautions
Pacing Leads and Cables Improper connection, displacement or fracture of leads or cables may result in pacemaker system failure. Inspect leads and cables for damage prior to each use.
Pacing System Adjustments Monitor the patient’s ECG and blood pressure and keep defibrillation equipment on standby, immediately available for emergency use during evaluation of stimulation and sensing thresholds, pacemaker and pacing lead connections and adjustments, and atrial high-rate burst pacing therapy.
Bipolar Lead Systems Bipolar lead systems are recommended because they are less susceptible to electromagnetic interference. Separation between the positive (+) electrode and negative (–) electrode of the same lead system should not exceed 15 mm (0.6 inches). Also, the atrial and ventricular lead systems should be positioned so that the electrodes of one system are a minimum of 4 cm (1.5 inches) from the electrodes of the other system and are at right angles to each other.
Unipolar Lead Systems Unipolar lead systems are not recommended because they are more susceptible to electromagnetic interference, which may result in inappropriate pacing. Unipolar lead systems should not be used in the dual-chambered pacing modes because the current path of one lead system may interfere with the current path of the other.
Atrial Sensing The atrial sensing threshold should be evaluated to ensure maximum electrogram amplitude and that an adequate atrial sensing threshold is obtained prior to programming to a mode that requires atrial sensing (DDD, DDI, or AAI).
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Chapter 2 Precautions Place the wires on the right atrial free wall, oriented along the direction of the myocardial fibers, approximately 1 cm apart. It is important to achieve a sensing threshold of at least 1.0 mV. The atrial sensitivity should be set to a minimum of one-half the measured threshold. This ensures a minimum safety margin of 2x the sensing threshold. Failure to follow this procedure can lead to delivery of asynchronous pulses.
Sensitivity Settings Since the sensitivity setting determines the smallest signal that can be sensed by the pacemaker, set the sensitivity dial to one-half the mV value of the patient’s sensitivity threshold (see “Sensing Threshold” on page 84). This setting will provide a 2x safety margin to ensure proper sensing. A more sensitive setting may be chosen to provide a greater safety margin. However, be aware that setting the sensitivity value too low (too sensitive) could result in inappropriate sensing of far field signals (e.g., sensing of R- or T-waves on the atrial channel or P-waves on the ventricular channel), leading to inappropriate inhibition of pacing pulses.
High Output and Maximum Sensitivity Although the pacemaker contains a safety pacing feature that prevents inappropriate inhibition of ventricular pacing due to far-field sensing, the simultaneous use of high output and maximum sensitivity (i.e., the lowest mV value) should be avoided.
Electrostatic Discharge (ESD) The pacing lead(s) provides a low-impedance pathway to the heart. Therefore, it is recommended that attending health care professionals discharge any static electricity by touching a large metal or conductive, grounded surface prior to touching the patient, the cable, the leads or the pacemaker. Also, neutralize any static electricity from the patient by touching the patient away from (i.e., distal to) the leads.
5388 Technical manual
Warnings, precautions, and adverse effects Precautions
Retrograde Conduction If retrograde P-waves are being sensed outside the rate-dependent, automatic Post-Ventricular-Atrial-Refractory Period (PVARP) setting, manually increase the PVARP until the retrograde waves fall inside the PVARP. Failure to follow this procedure may lead to a pacemaker mediated tachycardia (PMT).
Termination of Pacing Abrupt termination of pacing stimuli may result in intervals of asystole before an intrinsic rhythm is reestablished. Prior to terminating pacing, set the pacemaker to a demand mode, then gradually reduce the pacing rate below the patient’s intrinsic rate.
PAUSE Key Use the PAUSE key with care, since the patient is without pacing support (for a maximum of 10 seconds at a time) when PAUSE is pressed and held.
A-V Interval Programming long A-V intervals may result in pacing the ventricle during the vulnerable period of ventricular repolarization, thus precipitating ventricular arrhythmias in unstable patients.
EMERGENCY Key Use the EMERGENCY key only when high-output asynchronous pacing (DOO) is needed. When the EMERGENCY key is pressed, the emergency pacing mode is entered and remains in effect until the emergency pacing mode is deactivated. Press the ON key to deactivate emergency pacing mode. For more information, see “EMERGENCY (ASYNC.) Key” on page 29.
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Chapter 2 Environmental Precautions
Environmental Precautions The Model 5388 has been carefully designed and tested to ensure reliability during normal use. However, electronic devices are susceptible to many environmental stresses. Precautions should be taken to avoid damage to the unit, including (but not limited to) the precautions listed in this chapter.
5388 Technical manual
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Do not drop the unit or handle it in a way that might physically damage the device. The device may appear to work appropriately immediately after being dropped or mishandled, but operational damage may have occurred.
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Do not place the Model 5388 in any area where a patient may interact with it. Tampering with programmed parameters may have direct and serious patient health effects. The temporary pacemaker should be placed in an area that minimizes tampering with the device by unauthorized personnel (patients, visitors, etc.). Medtronic recommends the use of a protective cover, such as the Medtronic Model 5441 clear plastic cover, to minimize tampering.
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Avoid spilling fluid on the unit. The Model 5388 was carefully designed to minimize leakage, but fluid incursion may still occur. Medtronic recommends the use of a protective cover, such as the Medtronic Model 5409 plastic pouch, to minimize fluid incursion.
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Avoid contaminating the safety cable receptacle and connector pin receptacles with blood or other body fluids.
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Always use safe electrostatic discharge (ESD) procedures; this device could be adversely affected by ESD.
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Do not open the device. The seam joining the unit is designed to minimize fluid incursion and may not be effective if improperly opened and resealed. Furthermore, removing the label on the back of the unit may compromise the ESD barrier. Opening this unit will void the warranty.
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Do not sterilize the Model 5388 by gamma irradiation or steam (autoclave). See “Cleaning and Sterilization” on page 98 for more information.
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Rapid temperature changes may affect proper operation. Always allow the temperature of the device to stabilize in the environment in which the device will be used before attachment and operation (see page 104 for recommended storage and operation temperatures).
Warnings, precautions, and adverse effects Adverse Effects ■
Prolonged storage or operation of the device in high humidity may affect proper operation. Allow the device to completely dry after exposure to humidity.
Other environmental factors may impact proper performance of the unit in the hospital setting. Use of appropriate environmental health and safety practices will help prevent environmental damage to the unit.
Adverse Effects Temporary Pacemakers Potential adverse effects related to the use of temporary external pacemakers such as the Model 5388 include, but are not limited to: ■
Asystole following abrupt cessation of pacing;
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Inhibition or reversion in the presence of strong electromagnetic interference; and
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Initiation of a tachyarrhythmia or acceleration of an existing tachyarrhythmia.
Atrial High-Rate Burst Pacing Atrial high-rate burst pacing may result in the onset of tachycardia, acceleration of an existing tachycardia, or fibrillation. Application of temporary atrial high-rate burst pacing should be performed in a carefully monitored and controlled patient environment. Monitor the patient’s ECG and blood pressure, and keep defibrillation equipment on standby, immediately available for emergency use.
Dual Chamber Modes In the DVI, DDI, and DDD modes, the ventricular sense amplifier may sense the atrial pacing pulse. Reducing the atrial amplitude, the ventricular sensitivity, and/or repositioning the electrodes may be necessary to avoid this situation.
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