5348 Temporary Pacemaker Technical Manual Rev E March 2009

MEDTRONIC MODEL 5348 Technical Manual

Single Chamber Temporary Pacemaker

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Explanation of symbols Consult instructions for use

Type CF applied part

Conformité Européenne This symbol means that the device fully complies with European Directive 93/42/EEC.

0123 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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Humitidy limitation

Battery

Reorder number

Authorized representative in the European Community

EC REP Manufacturer

Date of manufacture

Serial number

5348 Technical manual

Contents 1

General description 11 Package Contents 12 Safety Features 12 Registration Card 12 Medtronic Warranty 13

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Intended use

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Contraindications 17 Atrial Pacing 17 Asynchronous Pacing 17 High-Rate Burst Therapy 17

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Warnings 19 Equipment Modification 19 Line-powered Equipment 19 Electrosurgery 19 Electromagnetic Interference (EMI) Defibrillation/Cardioversion 20 High-Rate Burst Therapy 20 Connecting the Lead System 20 Handling Indwelling Leads 21 Turning the Device On 21

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Precautions 23 Random Failures 23 Pacing Leads and Cables 23 Pacing System Adjustments 23 Unipolar Lead Systems 24 Sensitivity Settings 24 Electrostatic Discharge (ESD) 24 Termination of Pacing 24 Battery 24 Unauthorized Changes of Pacemaker Settings

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Environmental precautions

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Potential adverse effects Pacemakers 29

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Contents

High Rate Pacing 29 Lead Systems 29

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Controls, indicators, and other features 31 Base Level Pacing Controls 31 RATE 31 OUTPUT 31 SENSITIVITY 31 ON and OFF 33 Rapid Atrial Pacing (RAP) Controls 33 ENABLE/DISABLE 33 HOLD TO DELIVER 34 OUTPUT 34 Indicators 34 PACE 35 SENSE 35 LOW BATT. 35 Physical Features of the Model 5348 35 Control Covers 35 Battery 35 Connector Block 36 Attachment Ring and Bails 37 Functional Features of the Model 5348 37 Self-Testing 37 RAP Standby 38 Rate-Runaway Protection 38 Pulse Width 38 Synchronous (Demand) Modes (AAI/VVI) 38 Asynchronous Modes (AOO/VOO) 39 Blanking Periods 39 Refractory Periods 39 Reversion Response 39 Cables 40 Medtronic Models 5433A and 5433V Patient Cables 40 Medtronic Surgical Cable Models 5832 and 5832S 41 The Model 5409 Disposable Pouch 41 Description 41 Procedure for use 42

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Preparation for use 43 Battery Installation 43

Contents

Connecting the Model 5433A or 5433V Patient Cable to the Model 5348 44 Connecting the Pacing Lead System to the Model 5433A or 5433V Patient Cable 45 Connecting the Pacing Lead System Directly to the Model 5348 Pacemaker 46 10 Instructions for use 49 Turning the Model 5348 On and Off 49 Power-on Self-test 49 Procedures for Basic Pacing 50 Determining the Pacing Mode 50 Adjusting the Pacing Parameters 51 Determining Sensing Potentials 51 Determining Stimulation Thresholds 52 Procedure for Rapid Atrial Pacing (RAP) 53 Verify Connections 53 Enable the RAP Standby State 53 Adjust the RAP Rate 53 Delivering a RAP Burst 53 Adjusting Parameters During RAP Delivery 54 Returning to Basic Pacing Operation (Disabling RAP Standby) 54 11 Service information 55 Cleaning and Disinfection 55 Model 5348 Temporary Pacemaker 55 Model 5433A and 5433V Patient Cables 55 Safety and Technical Checks 56 Visual Inspection: 56 Functional Inspection: 56 Practical Measurements: 56 Service 57 12 Specifications

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General description

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The Medtronic® Model 5348 is a temporary, battery-powered, single chamber pacemaker designed primarily for temporary antibradycardia pacing therapy in asynchronous or demand (synchronous) modes. High-rate burst pacing therapy up to 800 min-1 (reciprocal minutes) (ppm [pulses per minute]), for tachyarrhythmias, is available in the asynchronous mode1. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).

Figure 1-1. The Medtronic Model 5348 Single Chamber Temporary Pacemaker and the Model 5433A or 5433V Patient Cable.

The device operates using a 9-volt alkaline or lithium battery, which is installed in a battery drawer at the bottom end of the pacemaker. Note: The Model 5348 is a constant current device; it emits a pulse with a current output that is maintained at a constant value. This value is set by the output control and does not vary with respect to the myocardium/lead impedance (as long as the myocardium/lead impedance stays between 200 Ω and 1000 Ω).

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For atrial use only.

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Chapter 1 Package Contents

Package Contents The Model 5348 is supplied with a 9-volt alkaline battery, technical literature, one Model 5409 disposable pouch, one Model 5433A atrial patient cable, one Model 5433V ventricular patient cable, a package of heartwire seals, and a carrying case. Check the package prior to use. Damaged packages should be returned to Medtronic (see back cover for the address).

Safety Features The Medtronic Model 5348 is designed to be reliable, simple to operate, and comfortable to hold. Safety features of the Model 5348 include: ■ Self-tests; ■ Low Battery indicator; ■ Continuous operation during battery replacement (at 80 min-1 [ppm], 10 mA) for a minimum of 15 seconds; ■ Reversible battery polarity; ■ Protective covers over the controls and a rubber seal covering the heartwire receptacles; ■ Safe “power-off” operation (Two buttons must be pressed simultaneously to turn the device off.); ■ Cautionary label at the Rapid Atrial Pacing (RAP) controls; ■ Detents (mechanical restrictions of dial movement) on the RATE and SENSITIVITY dials to highlight extremes or potentially hazardous settings; ■ Safety cables (recessed pins); ■ Runaway rate protection; ■ Protection from defibrillation shock up to 360 watt-seconds; ■ Electrostatic protection; and ■ Minimized susceptibility to electromagnetic and magnetic interference.

Registration Card Please complete the registration card and return it to Medtronic. Consult the back cover of this manual for the address. U.S. customers: use the address labels provided.

5348 Technical manual

General description Medtronic Warranty

Medtronic Warranty For complete device warranty and accessories disclaimer of warranty, see the accompanying warranty documents.

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Intended use

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The Medtronic Model 5348 pacemaker is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The Model 5348 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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Temporary 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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Temporary support of a patient following cardiac surgery;

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Acute myocardial infarction complicated by heart block; and

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High-rate burst pacing for the treatment of supraventricular tachyarrhythmias.

The Model 5348 can be used to determine sensing potentials of temporary and permanently implanted lead systems. When implanting a permanent pacemaker, however, Medtronic recommends the use of a Medtronic Pacing System Analyzer.

Contraindications

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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.

Atrial Pacing 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.

High-Rate Burst Therapy High-rate burst therapy is intended for use in the atrium only. Use in the ventricle could result in life-threatening arrhythmias.

Warnings

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Equipment Modification Do not modify this equipment. Modifications could impact device effectiveness and adversely affect patient safety.

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 fibrillation 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.

Electrosurgery Electrosurgery can induce ventricular fibrillation, and thus should never be used within 15 cm (6 inches) of an implanted lead system.

Electromagnetic Interference (EMI) All pacemakers operating in the demand mode respond to intracardiac potentials of a magnitude of a few millivolts. They are inherently sensitive to some external fields. In the presence of excessive levels of interference the Model 5348 may inhibit completely or revert to asynchronous operation, pacing at the rate set by the RATE dial. It is recommended that the device be set to an asynchronous mode when operated in the presence of strong electromagnetic interference (EMI). Some sources of excessively strong EMI which may temporarily affect the operation of the Model 5348 are: ■

Electrosurgical equipment;

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Diathermy equipment;

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Chapter 4 Defibrillation/Cardioversion ■

Some medical telemetry equipment (when operated within one meter [several feet] of the pacemaker);

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Communication transmitters such as cellular phones and “walkie talkies”;

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Communication transmitters in emergency transport vehicles (in the presence of an active pacemaker); and

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Magnetic Resonance Imaging (MRI) equipment.

Defibrillation/Cardioversion Defibrillation discharges of 360 watt-seconds have not affected the Model 5348 in laboratory tests. However, for maximum safety it is recommended that the paddles not be placed near the Model 5348 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.

High-Rate Burst Therapy Use of high rates in the atrium could result in high-rate conduction to the ventricle. Defibrillation equipment should be immediately available during high-rate or burst pacing.

Connecting the Lead System The patient cable should be connected to the temporary pacemaker before the lead system is connected to the patient cable.

5348 Technical manual

Warnings Handling Indwelling Leads

Handling Indwelling Leads When handling indwelling leads, the terminal pins or exposed metal are not to be touched nor be allowed to contact electrically conductive or wet surfaces.

Turning the Device On All patient, lead, cable and device connections should be made before the pacemaker is powered on.

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Precautions

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Random Failures The physician should be aware that the Model 5348 Temporary Pacemaker can fail due to a number of reasons, such as random component failure, battery depletion, and mishandling. Possible malfunctions of the Model 5348 can include: ■ No output; ■ No sensing; ■ False indicator light signals; ■ Increased or decreased rate, output pulse width, or output amplitude; ■ Reversion to asynchronous pacing; and ■ Loss of control of rate, output, sensitivity or power. If loss of control of rate, output, sensitivity or power occurs, and it would be appropriate to temporarily stop pacing the patient, attempt to correct the condition by turning the device off and then on. If this does not correct the condition, remove the battery for 30 to 60 seconds, reinsert the battery, and turn the device back on.

Pacing Leads and Cables Improper connection, displacement or fracture of leads or cables may also result in pacemaker system failure.

Pacing System Adjustments During stimulation threshold measurements, sensing threshold measurements, and other adjustments, stimuli may be inadvertently delivered into a vulnerable period of the cardiac cycle. Monitor the patient’s ECG and keep defibrillation equipment on standby, immediately available for emergency use during pacing lead attachment, pacemaker connection and adjustment, measurements of stimulation thresholds or sensed potentials, and application of burst pacing therapy.

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Chapter 5 Unipolar Lead Systems

Unipolar Lead Systems Bipolar lead systems are recommended because they are less susceptible to electromagnetic interference. If a unipolar lead system is used, the pacing electrode should be connected to the negative (-) pacemaker terminal; the indifferent (subcutaneous) lead should be connected to the positive (+) terminal. It is important to observe and match voltage polarity markings of all components when connecting the lead system.

Sensitivity Settings Since the sensitivity setting determines the smallest signal that can be sensed by the pacemaker, set the sensitivity dial to at least one-half the mV value of the patient’s sensitivity threshold (see “Determining Sensing Potentials”). This will provide an adequate safety margin to ensure proper sensing. Be aware that setting the sensitivity value extremely low (the most sensitive) could result in inappropriate sensing of far field signals (e.g., sensing of R or T waves on the atrial lead or P waves on the ventricular lead), leading to inappropriate inhibition of pacing pulses.

Electrostatic Discharge (ESD) The pacing lead(s) provides a low-impedance pathway to the heart. Therefore, it is recommended that the attending health professional discharge any personal static electricity immediately prior to touching the patient, the cable, leads or pacemaker.

Termination of Pacing Abrupt termination of pacing stimuli may result in periods of asystole before an intrinsic rhythm is established. Prior to terminating pacing, a gradual reduction in pacing rate, using the demand mode, is recommended.

Battery Replace the battery for each new patient, and when the low battery indicator appears during device operation. Check the battery status at least twice daily. Replace alkaline batteries no less than every seven days during continuous use of the temporary pacemaker. 5348 Technical manual

Precautions Unauthorized Changes of Pacemaker Settings Use of batteries with different physical dimensions from that of the recommended batteries may result in erratic, or no pacing output. 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.

Unauthorized Changes of Pacemaker Settings Do not place the Model 5348 in any area where patients may interact with it. The temporary pacemaker should be placed in an area that minimizes tampering with the device by unauthorized personnel (patients, visitors, etc.).

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Environmental precautions

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The Model 5348 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) those listed in this chapter. ■

Do not drop the unit or mishandle it in a way that might physically damage the device. Even if the device appears to work immediately after being dropped or damaged, operational damage may have occurred.

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Avoid spilling fluid on the unit. The Model 5348 was carefully designed to minimize leakage, but fluid incursion still may occur. Medtronic recommends the use of a protective device such as the Model 5409 plastic pouch. However, a plastic pouch may not completely prevent fluid incursion.

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Avoid contaminating the safety cable receptacle and heartwire 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, breaking the label on the unit may compromise the ESD barrier. Opening this unit will void the warranty (see "Medtronic Warranty" in Chapter 1 for more information).

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Do not sterilize the Model 5348 by gamma irradiation and do not steam-sterilize (autoclave) the device. See “Cleaning and Disinfection” in Chapter 11 for more information.

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Rapid temperature changes may affect proper operation. Always allow the temperature to stabilize in the environment in which the device will be used before attachment and operation of the device (see “Specifications” for recommended storage and operation temperatures).

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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 good health management practices will help to prevent environmental damage to the unit.

Potential adverse effects

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Pacemakers Potential adverse effects related to the use of temporary external pacemakers such as the Model 5348 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.

High Rate Pacing High-rate pacing may result in the onset of tachycardia, acceleration of an existing tachycardia, or fibrillation. Application of temporary high-rate pacing should be performed in a carefully monitored and controlled patient environment. Monitor the patient’s ECG and keep defibrillation equipment on standby, immediately available for emergency use during high-rate pacing.

Lead Systems Potential adverse effects related to the use of pacing lead systems used in conjunction with the Model 5348 Pacemaker include, but are not limited to: ■

Inappropriate lead connections;

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Inadvertent disconnection of the lead system;

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Lead fracture or displacement causing intermittent or complete loss of capture and/or sensing;

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Myocardial irritability resulting in fibrillation;

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Perforation and tamponade;

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Infarction; and

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Pericarditis.