Technical Manual
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5392 Dual Chamber Temporary External Pacemaker
Technical Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners. Medtronic
Medtronic
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Contents 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7
Overview... 5 About this manual... 5 Symbols... 5 General description... 7 Intended use... 9 Package contents... 10 Compatible accessory components... 10 Contraindications... 10
2 2.1 2.2 2.3 2.4
Warnings, precautions, and adverse events... 12 Warnings... 12 Precautions... 14 Environmental precautions... 17 Adverse effects... 19
3 3.1 3.2 3.3 3.4
Controls, indicators, and other features... 20 Controls... 20 Indicators... 24 RATE, A OUTPUT, and V OUTPUT parameters... 27 Lower screen functions... 28
4 4.1 4.2 4.3 4.4 4.5 4.6
Preparation for use... 31 Checks prior to use... 31 Physical features... 31 Batteries... 33 Battery installation and replacement... 35 Connector Setup... 37 Placement during use... 41
5 5.1 5.2 5.3
Instructions for use... 42 Basic operation... 42 Thresholds... 51 Pacing parameter adjustments... 57
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5.4 5.5 5.6
Timing violations... 68 Rapid Atrial Pacing (RAP)... 70 Automatic responses... 73
6 6.1 6.2 6.3 6.4
Cleaning, disinfecting, and maintenance... 77 Cleaning and disinfecting the temporary pacemaker... 77 Safety and technical checks... 77 Service... 79 Product life... 79
7 7.1 7.2
Specifications... 80 Device specifications... 80 Pacing information tables... 84
8 8.1
Special notice... 87 Special notice for the temporary pacemaker... 87
9 9.1
Troubleshooting... 88 Troubleshooting... 88
Index... 98
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1 Overview 1.1 About this manual This manual describes the features and functions of the Medtronic Model 5392 Dual Chamber Temporary External Pacemaker (referred to as the “temporary pacemaker”).
1.2 Symbols Explanation of symbols System meets the applicable Canadian and U.S. electrical safety standards. Consult instructions for use
Caution
Conformité Européenne (European Conformity) This symbol means that the device fully complies with European Directive 93/42/EEC. Temporary external pacemaker
Atrium chamber designator
Ventricle chamber designator
For atrial use
For ventricular use
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Explanation of symbols Defibrillation-proof type CF applied part
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
Dual chamber temporary pacemaker Product documentation
Accessories
Storage temperature limitation Humidity limitation
Battery
Reorder number
Authorized representative in the European Community
Manufacturer/Date of manufacture
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Explanation of symbols Date of manufacture
Serial number
Non-ionizing electromagnetic radiation
Notice of proper disposal
This product conforms to IP21. There are no openings that allow the user to insert a finger or similarly sized objects. The product is resistant to dripping water or vertically falling drops. China RoHS
MR Unsafe. An item that is known to pose hazards in all MR environments. 5392 carrying case
1.3 General description The temporary pacemaker is a battery-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The temporary pacemaker provides 7 selectable modes of pacing therapy: DDD, DDI, DOO, AAI, AOO, VVI, and VOO. High-rate, burst pacing therapy up to 800 ppm for atrial tachyarrhythmias is available in the asynchronous mode.1 The temporary pacemaker typically is connected to temporary transvenous, epicardial, or myocardial pacing leads in a bipolar configuration, using either Medtronic patient cables, Medtronic surgical cables, or compatible patient cables (see Section 1.6).
1 For atrial use only.
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The temporary pacemaker operates using 2 LR6-sized (AA-sized) alkaline batteries (see Section 7.1). The batteries are installed in the battery drawer at the bottom of the temporary pacemaker. Note: The temporary pacemaker 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.
1.3.1 Safety features The temporary pacemaker includes the following safety features: ●
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 off the temporary pacemaker to avoid unintended shutdown
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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 Section 7.1)
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Electrostatic protection
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Minimized susceptibility to electromagnetic and magnetic interference
1.3.2 Operating features The temporary pacemaker includes the following operating features: ●
Single chamber pacing modes – AAI, AOO, VVI, and VOO
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Dual chamber pacing modes – DDD, DDI, DOO
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No pacing therapy – OOO
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Easy-to-view rate and output settings
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Pacing and sensing status indicators – shows temporary pacemaker interaction with the heart
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Low battery indicator – indicates when to replace the batteries
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Four-dial operation – provides therapy for most pacing needs
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Rate-dependent parameters – rate adjustment automatically sets Upper Rate, PVARP, and A-V Interval Technical Manual
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Lock/Unlock key – safeguards against unintentional parameter changes
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Lower screen messages – to aid in device operation
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Menu screens – for adjusting additional parameters, including sensitivity, rate-dependent parameters; for Rapid Atrial Pacing (RAP); for directly selecting 7 pacing modes (DDD, DDI, DOO, AAI, AOO, VVI, and VOO) or selecting no pacing therapy (OOO). Pause key – to suspend pacing and sensing to view the patient’s intrinsic rhythm DOO/Emergency key – starts emergency dual chamber asynchronous (DOO) pacing at maximum atrial and ventricular outputs
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Automatic sensitivity adjustment
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Automatic mode switch during atrial arrhythmias
1.4 Intended use The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. Train clinical personnel on the functionality and use of the temporary pacemaker prior to initial use of the device, as needed, and per clinic procedures. Contact your Medtronic representative to schedule training. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. 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 before permanent pacemaker implantation 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
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Atrial tachyarrhythmias that require high-rate burst pacing for treatment
1.5 Package contents The temporary pacemaker is supplied with the following items: ●
Two LR6-sized (AA-sized) alkaline batteries (see Section 7.1)
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Literature
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Carrying case
1.6 Compatible accessory components The following compatible accessory components are available for the temporary pacemaker: ●
Medtronic Model 5409 Disposable Pouch
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Medtronic Model 53922 Disposable Cover
The following reusable compatible cables are available for the temporary pacemaker: ●
Medtronic Patient Cables (Model 5433 family)
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Medtronic Surgical Cables (Model 5832 family)
The following disposable compatible cables are available for the temporary pacemaker: ●
Medtronic Surgical Cable (Model 5833 family)
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Medtronic Patient Cables (Model 5846 family)
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Medtronic Patient Cables (Model 5487 family)
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Compatible temporary transvenous, epicardial, or myocardial pacing leads
Contact your local Medtronic representative to order them.
1.7 Contraindications There are no known contraindications for the use of temporary pacing as a means to control heart rate. However, the patient’s age and medical condition may dictate the type of temporary pacemaker and lead system that the physician uses. 10
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1.7.1 Atrial sensing Pacing modes that 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.
1.7.2 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.
1.7.3 Asynchronous pacing Asynchronous pacing is contraindicated in the presence of intrinsic cardiac rhythms.
1.7.4 Atrial high-rate burst pacing therapy Atrial high-rate burst pacing therapy is intended for use in the atrium only. High-rate burst pacing is contraindicated in the ventricle; it may result in life-threatening arrhythmias.
1.7.5 Concomitant pacing Temporary pacing is contraindicated in the presence of another pacing system. Do not use the temporary pacemaker to pace a patient while another pacing system is also actively pacing the patient. Concomitant pacing can occur where both pacing systems compete to pace the patient. If concomitant pacing occurs, the temporary pacemaker may not be able to pace the patient, or may pace the patient asynchronously. Concomitant pacing could cause the temporary pacemaker to potentially pace into a T-Wave or result in a pacemaker-mediated tachycardia.
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2 Warnings, precautions, and adverse events 2.1 Warnings Patient monitoring – Monitor the patient continuously while the temporary pacemaker is in use to ensure it is operating properly and delivering appropriate therapy to the patient. Equipment modification – Do not modify the temporary pacemaker. Modifications could impact the temporary pacemaker effectiveness and adversely affect patient safety. Temporary pacemaker compatibility – Only connect items that have been specified as part of the temporary pacemaker or that have been specified as being compatible with the temporary pacemaker. Temporary pacemaker use – The temporary pacemaker is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Defibrillation/cardioversion – The temporary pacemaker is protected from damage caused by internal defibrillation discharges up to 50 J (watt-seconds) and external defibrillation discharges up to 360 J. However, it is recommended that paddles be placed as far away from the temporary pacemaker or the lead system as is practical. Whenever possible, for the safety of the patient, disconnect the temporary pacemaker from the implanted lead system before defibrillating or cardioverting. Excessive defibrillation energy can damage the temporary pacemaker. This can result in a large current flowing through the implanted lead system and temporary pacemaker, which could reduce intended defibrillation energy delivered to the patient or cause myocardial damage. If damage to the temporary pacemaker is suspected due to defibrillation, disconnect it from the patient and return it to Medtronic for service. Line-powered equipment – An implanted lead or a lead with an 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 loss of pacing from oversensing or tachyarrhythmias by inducing current on the leads, and thus should never be used within 15 cm (6 in) of the pacemaker/lead system. Ablation (RF ablation or microwave ablation) – Ablation is a surgical technique in which radio frequency (RF) or microwave energy is used to destroy cells by creating heat. Ablation used in cardiac device patients may result in, but is not limited to, induced ventricular tachyarrhythmias, oversensing, unintended tissue damage, device damage, or device malfunction.
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Pulse-modulated ablation systems may pose higher risk for induced ventricular tachyarrhythmias. Medtronic cardiac devices are designed to withstand exposure to ablation energy. To mitigate risks, observe the following precautions: ●
Ensure that temporary pacing and defibrillation equipment is available.
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Avoid direct contact between the ablation catheter and the temporary leads.
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Position the return electrode patch so that the electrical current pathway does not pass through or near the device and leads. Continuously monitor the patient during ablation with at least two separate methods, such as arterial pressure display, ECG, manual monitoring of the patient’s rhythm (taking pulse) or monitor by some other means such as ear or finger pulse oximetry, or Doppler pulse detection.
To avoid or mitigate the effects of oversensing, if appropriate for the patient, initiate asynchronous pacing. Electromagnetic interference (EMI) – Pacemakers operating in the demand mode respond to intracardiac potentials with magnitudes of a few mV. This level of sensitivity makes the temporary pacemaker inherently sensitive to some external fields. In the presence of excessive levels of interference, the temporary pacemaker may inhibit completely or revert to asynchronous operation, pacing at the rate set by the RATE dial. It is recommended that the temporary pacemaker be set to an asynchronous pacing 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 that may temporarily affect the operation of the temporary pacemaker include the following: ●
Electrosurgical equipment
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Diathermy equipment
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Some medical telemetry equipment (when operated within 1 m [about 3 feet] of the pacemaker) Communication transmitters such as cellular phones, “walkie talkies”, and transmitters in emergency transport vehicles Magnetic resonance imaging (MRI) equipment
Atrial High-Rate Burst Pacing Therapy (Rapid Atrial Pacing) – 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 cables should be connected to the temporary pacemaker before the lead(s) is connected to the patient cable(s). Technical Manual
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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. MR unsafe – The temporary pacemaker is MR unsafe. Do not bring the temporary pacemaker into Zone 4 (magnet room), as defined by the American College of Radiology.
2.2 Precautions Random failures – The physician should be aware that operational failure of the temporary pacemaker can occur as the result of battery depletion, mishandling, or random component failure. Possible operational failures of the temporary pacemaker can include the following: ●
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
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 temporary pacemaker from the patient and return it to Medtronic for service. ●
Temporary pacemaker repair – Do not attempt to repair the temporary pacemaker. Only a qualified Medtronic Technical Services representative can repair the temporary pacemaker. Contact Medtronic at the telephone number on the back cover of this manual if the temporary pacemaker requires service. Service condition – Before each use, evaluate the temporary pacemaker for damage and observable defects. Do not use the temporary pacemaker if the case is cracked, the controls are not functioning, the displays are not working, or if the controls, displays, or connectors are broken. If the temporary pacemaker has any observable defects, contact Medtronic at the telephone number on the back cover of this manual for service. Cleaning, disinfection, and sterilization – Clean and disinfect the temporary pacemaker before each use for a new patient. Clean and sterilize the reusable cables before each use for a new patient. Batteries – Only install the recommended batteries in the temporary pacemaker. Batteries with different physical dimensions, non-alkaline (e.g., lithium or rechargeable) or batteries with contamination on the battery terminals, may result in erratic operation of the temporary
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pacemaker, no pacing output, or damage to the temporary pacemaker, specifically to the battery compartment. Replace the batteries for each new patient and when the low battery indicator flashes during temporary pacemaker operation. Only use new, fresh batteries that have not passed their expiration date. Inspect battery terminals for contamination. Using batteries with contaminated terminals can result in the temporary pacemaker turning off, decreased battery life, or corrosion to the battery compartment. 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 flashes. Verify that the battery drawer is fully closed and latched in place. Failure to ensure that the battery drawer is fully latched may result in loss of power. Continued temporary pacemaker operation is not an indication that the battery drawer is properly latched. Battery installation – Ensure that the new, fresh batteries are installed with the correct battery polarity by verifying that the batteries align with the polarity markings on the inside of the battery drawer. The temporary pacemaker requires proper battery polarity for operation. After installing the batteries, ensure that the battery status indicator displays full battery power and that the low battery indicator is not flashing. The temporary pacemaker may temporarily continue to pace and sense with weak, dead, or incorrectly installed batteries. 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 before each use. Pacing system adjustments – Monitor the patient’s ECG and blood pressure. 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. Default DDD pacing mode – The default power-up settings for the DDD pacing mode are not always appropriate for every patient or situation. Select the appropriate pacing mode to meet the pacing needs of the patient. Patient monitoring after defibrillation – Monitor the patient after a defibrillation has occurred to verify that the temporary pacemaker and the cable/lead systems are still delivering the appropriate 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 in). Place the atrial and ventricular lead systems at right angles to each other. Verify that the electrodes of one system are a minimum of 4 cm (1.5 in) from the electrodes of the other system. Failure Technical Manual
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to follow these spacing recommendations could result in oversensing. Clinical risks for not following these spacing recommendations include, but are not limited to, loss of pacing output, asynchronous ventricular pacing, and pacemaker mediated tachycardia. 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. Dual chamber pacing modes – Do not configure the temporary pacemaker in any of the dual chamber pacing modes unless both channels are connected to the heart. If the temporary pacemaker is configured in a dual chamber pacing mode and one of the channels is not connected, the open channel could pick up unintended noise. The noise can be interpreted as a sensed event and can lead to events such as, but not limited to, asynchronous ventricular pacing, unintended pacing inhibition, or ventricular tachycardia. Avoid use of dual chamber pacing modes without an atrial connection as this could, in rare circumstances, result in inappropriate delivery of a ventricular pace on an intrinsic T-wave. Atrial sensing – When programming to a mode that requires atrial sensing, the sensing threshold should be evaluated for sufficient safety margin. Place the temporary pacing lead on the right atrial free wall, oriented along the direction of the myocardial fibers, approximately 1 cm (0.4 in) apart. It is important to achieve a sensing threshold of at least 1.0 mV. Set atrial sensitivity to a minimum of one-half the measured threshold. The setting ensures a minimum safety margin of two times the sensing threshold. Failure to follow this procedure can lead to delivery of asynchronous pulses. Sensing thresholds – Do not use the temporary pacemaker to determine sensing thresholds for permanently implanted lead systems. When implanting a permanent pacemaker, Medtronic recommends the use of a pacing system analyzer (PSA). 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. 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 (for example, sensing of R-waves or T-waves on the atrial channel or P-waves on the ventricular channel), leading to inappropriate inhibition of pacing pulses. Sensitivity threshold testing – Complete the sensitivity threshold testing to determine the appropriate settings for sensitivity. Clinical risks for failure to perform this step include, but are not limited to, asynchronous ventricular pacing and pacemaker mediated tachycardia. Output threshold testing – Complete the output threshold testing to determine the appropriate settings for output. Clinical risks for failure to perform this step include, but are
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not limited to, loss of capture, retrograde conduction, induced tachycardia, and loss of hemodynamic support. High output and maximum sensitivity – Although the temporary 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 (that is, the lowest mV value) in the presence of atrial flutter or fibrillation can result in fatal arrhythmias. 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 before touching the patient, the cable, the leads, or the temporary pacemaker. Also, neutralize any static electricity from the patient by touching the patient away from (i.e., distal to) the leads. 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 re-established. Before terminating pacing, set the temporary 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 receives no pacing support (for a maximum of 10 s at a time) when the Pause key 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. DOO/Emergency key – Use the DOO/Emergency key only when high-output asynchronous pacing (DOO) is needed. When the DOO/Emergency key is pressed, the emergency pacing mode is entered and remains in effect until the emergency pacing mode is deactivated. Press the Enter key to deactivate emergency pacing mode.
2.3 Environmental precautions The temporary pacemaker has been carefully designed and tested to ensure reliability during normal use. However, electronic devices are susceptible to many environmental stresses. To avoid damage to the temporary pacemaker, observe the following precautions: ●
Do not drop the temporary pacemaker or handle it in a way that might physically damage it. The temporary pacemaker may appear to work appropriately immediately after being dropped or mishandled, but operational damage may have occurred. Perform safety and technical checks if the temporary pacemaker has been dropped.
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Do not place the temporary pacemaker 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 (for example, patients or visitors). Medtronic recommends use of the Model 53922 Disposable Cover to reduce the risk of tampering with the programmed parameters. Avoid spilling fluid on the temporary pacemaker. The temporary pacemaker was carefully designed to minimize leakage, but fluid incursion may still occur. Medtronic recommends the use of a protective cover, such as the Model 5409 Disposable Pouch, to minimize fluid incursion. Avoid contaminating the patient cable receptacles with blood or other body fluids. Always use safe electrostatic discharge (ESD) procedures; the temporary pacemaker could be adversely affected by ESD. Do not open the temporary pacemaker. 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 temporary pacemaker may compromise the ESD barrier. Opening the temporary pacemaker voids the warranty. Do not sterilize the temporary pacemaker by gamma irradiation or steam (autoclave). Do not store the temporary pacemaker with the batteries in the battery drawer. Remove the batteries when the temporary pacemaker is not in use. Rapid temperature changes may affect proper operation. Always allow the temperature of the temporary pacemaker to stabilize in the environment in which it will be used before attachment and operation. Prolonged storage or operation of the temporary pacemaker in high humidity may affect proper operation. Allow the temporary pacemaker to completely dry after exposure to humidity.
Other environmental factors may impact proper performance of the temporary pacemaker in the hospital setting. Use of appropriate environmental health and safety practices will help prevent environmental damage to the temporary pacemaker.
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2.4 Adverse effects Temporary pacemakers – Potential adverse effects related to the use of the temporary pacemaker include, but are not limited to the following: ●
Asystole following abrupt cessation of pacing
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Inhibition or reversion in the presence of strong electromagnetic interference
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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. Keep defibrillation equipment on standby and immediately available for emergency use. Dual chamber modes – In the DDI and DDD pacing 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. Safety margins – Determine an adequate safety margin for sensing and pacing in both the ventricle and atrium. Failure to do so may result in inappropriate pacing. Lead systems – Potential adverse effects related to the use of pacing lead systems used in conjunction with the temporary pacemaker include, but are not limited to the following: ●
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
Perforation and tamponade Other potential adverse effects related to the use of any implanted lead system include, but are not limited to, the following: ●
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Myocardial irritability resulting in fibrillation
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Infarction
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Pericarditis
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Body rejection phenomena (local tissue reaction)
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Muscle and nerve stimulation
Infection Nerve or muscle stimulation can be caused by pacing lead contact with the nerve or muscle tissue and/or by high-output settings. The stimulation may be controlled by repositioning or replacing the electrode, or by reducing the output pulse amplitude. ●
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3 Controls, indicators, and other features 3.1 Controls The dials and keys used to control the functions and parameter settings of the temporary pacemaker are described in this chapter. Note: All adjustments to the RATE, A (Atrial) OUTPUT, and V (Ventricular) OUTPUT dials take effect within the next two pacing cycles.
3.1.1 Temporary pacemaker controls and indicators The upper screen indicators display the RATE, A OUTPUT, and V OUTPUT values, pacing and sensing status, the currently selected pacing mode, the battery status, and the lock indicator. See Figure 1. The controls next to the upper screen are used for the following: ●
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To adjust the RATE, A OUTPUT, and V OUTPUT values using the RATE, A OUTPUT, and V OUTPUT dials To select high-output, dual-chamber asynchronous pacing (DOO for emergency) by pressing the DOO/Emergency key To turn on or turn off the temporary pacemaker by pressing the On/Off key
Figure 1. Controls and indicators for the upper screen
PACE
A
SENSE
PACE
V
SENSE
RATE
30
200
ppm
A OUTPUT
0
20
mA
V OUTPUT
0
20
25
mA
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