Dual Chamber Temporary External Pacemaker

1 5392 Dual Chamber Temporary External PacemakerTechnical ManualCaution: Federal law (USA) restricts this device to sale by or on the order ofa following list includes trademarks or registered trademarks of Medtronic in the UnitedStates and possibly in other countries. All other trademarks are the property of their About this General Intended Package Compatible accessory Warnings, precautions, and adverse Environmental Adverse Controls, indicators, and other RATE, A OUTPUT, and V OUTPUT Lower screen functions ..284 Preparation for Checks prior to Physical Battery installation and Connector Placement during Instructions for Basic Pacing parameter Timing Rapid Atrial Pacing (RAP).

2 Automatic Cleaning, disinfecting, and Cleaning and disinfecting the Temporary Safety and technical Product Device Pacing information Special Special notice for the Temporary Manual1 About this manualThis manual describes the features and functions of the Medtronic Model 5392 DualChamber Temporary External Pacemaker (referred to as the Temporary Pacemaker ). SymbolsExplanation of symbolsSystem meets the applicable Canadian and electrical instructions for useCautionConformit Europ enne (European Conformity)This symbol means that the device fully complies with EuropeanDirective 93/42 External pacemakerAtrium Chamber designatorVentricle Chamber designatorFor atrial useFor ventricular useMedtronic5392 Technical Manual5 Explanation of symbolsDefibrillation-proof type CF applied partDo not dispose of this product in the unsorted municipal wastestream.

3 Dispose of this product according to local regulations. for instructions on proper disposalof this US audiences onlyPackage contentsDual Chamber Temporary pacemakerProduct documentationAccessoriesStorage temperature limitationHumidity limitationBatteryReorder numberAuthorized representative in the European CommunityManufacturer/Date of manufactureMedtronic53926 Technical ManualExplanation of symbolsDate of manufactureSerial numberNon-ionizing electromagnetic radiationNotice of proper disposalThis product conforms to IP21. There are no openings that allow theuser to insert a finger or similarly sized objects. The product isresistant to dripping water or vertically falling RoHSMR Unsafe. An item that is known to pose hazards in all MR carrying General descriptionThe Temporary Pacemaker is a battery-powered, dual Chamber , Temporary pacemakerdesigned primarily for Temporary antibradycardia pacing therapy.

4 The Temporary pacemakerprovides 7 selectable modes of pacing therapy: DDD, DDI, DOO, AAI, AOO, VVI, and , burst pacing therapy up to 800 ppm for atrial tachyarrhythmias is available in theasynchronous Temporary Pacemaker typically is connected to Temporary transvenous, epicardial, ormyocardial pacing leads in a bipolar configuration, using either Medtronic patient cables,Medtronic surgical cables, or compatible patient cables (see Section ).1 For atrial use Manual7 The Temporary Pacemaker operates using 2 LR6-sized (AA-sized) alkaline batteries (seeSection ). The batteries are installed in the battery drawer at the bottom of the : The Temporary Pacemaker is a constant current device. When it emits a pulse, thecurrent output is maintained at a constant value.

5 This value is set by the output control anddoes not Safety featuresThe Temporary Pacemaker includes the following safety features: Self-test function Low battery indicator Lock feature to prevent accidental change of parameters Safe, two-step operation to turn off the Temporary Pacemaker to avoid unintendedshutdown Runaway rate protection Protection from defibrillation shock Continuous operation during battery replacement (see Section ) Electrostatic protection Minimized susceptibility to electromagnetic and magnetic Operating featuresThe Temporary Pacemaker includes the following operating features: Single Chamber pacing modes AAI, AOO, VVI, and VOO Dual Chamber pacing modes DDD, DDI, DOO No pacing therapy OOO Easy-to-view rate and output settings Pacing and sensing status indicators shows Temporary Pacemaker interaction with theheart Low battery indicator indicates when to replace the batteries Four-dial operation provides therapy for most pacing needs Rate-dependent parameters rate adjustment automatically sets Upper Rate, PVARP,and A-V IntervalMedtronic53928 Technical Manual Lock/Unlock key safeguards against unintentional parameter changes Lower screen messages to aid in device operation Menu screens for adjusting additional parameters, including sensitivity,rate-dependent parameters; for Rapid Atrial Pacing (RAP).

6 For directly selecting 7pacing modes (DDD, DDI, DOO, AAI, AOO, VVI, and VOO) or selecting no pacingtherapy (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 atmaximum atrial and ventricular outputs Automatic sensitivity adjustment Automatic mode switch during atrial Intended useThe Temporary Pacemaker is used with a cardiac pacing lead system for Temporary single ordual Chamber pacing in a clinical environment by trained personnel. Train clinical personnelon the functionality and use of the Temporary Pacemaker prior to initial use of the device, asneeded, and per clinic procedures. Contact your Medtronic representative to Temporary Pacemaker can be used where short-term demand (synchronous) orasynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes.

7 Thetemporary Pacemaker must be used in an environment where the patient is monitoredcontinuously to ensure that it is operating properly and delivering appropriate therapy to indications for Temporary cardiac pacing include, but are not limited to, the following: Complete heart block Sinus bradycardia Sick sinus syndrome Bradycardia with congestive heart failure Atrial and/or ventricular arrhythmias Cardiac arrest Support, management, and evaluation of a patient before permanent pacemakerimplantation Support during permanent Pacemaker replacementMedtronic5392 Technical Manual9 Cardiac complications during invasive or surgical procedures Support following cardiac surgery Acute myocardial infarction complicated by heart block Atrial tachyarrhythmias that require high-rate burst pacing for Package contentsThe Temporary Pacemaker is supplied with the following items.

8 Two LR6-sized (AA-sized) alkaline batteries (see Section ) Literature Carrying Compatible accessory componentsThe following compatible accessory components are available for the temporarypacemaker: Medtronic Model 5409 Disposable Pouch Medtronic Model 53922 Disposable CoverThe following reusable compatible cables are available for the Temporary Pacemaker : Medtronic Patient Cables (Model 5433 family) Medtronic Surgical Cables (Model 5832 family)The following disposable compatible cables are available for the Temporary Pacemaker : Medtronic Surgical Cable (Model 5833 family) Medtronic Patient Cables (Model 5846 family) Medtronic Patient Cables (Model 5487 family) Compatible Temporary transvenous, epicardial, or myocardial pacing leadsContact your local Medtronic representative to order ContraindicationsThere are no known contraindications for the use of Temporary pacing as a means to controlheart rate.

9 However, the patient s age and medical condition may dictate the type oftemporary Pacemaker and lead system that the physician Atrial sensingPacing modes that allow sensing in the atrium to trigger a ventricular response arecontraindicated in the presence of rapid atrial arrhythmias, such as atrial fibrillation or Atrial pacingAtrial pacing is ineffective in the presence of atrial fibrillation or Chamber atrial pacing is contraindicated in the presence of AV conduction Asynchronous pacingAsynchronous pacing is contraindicated in the presence of intrinsic cardiac Atrial high-rate burst pacing therapyAtrial high-rate burst pacing therapy is intended for use in the atrium only. High-rate burstpacing is contraindicated in the ventricle; it may result in life-threatening Concomitant pacingTemporary pacing is contraindicated in the presence of another pacing not use the Temporary Pacemaker to pace a patient while another pacing system is alsoactively pacing the patient.

10 Concomitant pacing can occur where both pacing systemscompete to pace the 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 temporarypacemaker to potentially pace into a T-Wave or result in a Pacemaker -mediated Manual112 Warnings, precautions, and adverse WarningsPatient monitoring Monitor the patient continuously while the Temporary Pacemaker is inuse to ensure it is operating properly and delivering appropriate therapy to the modification Do not modify the Temporary Pacemaker . Modifications couldimpact the Temporary Pacemaker effectiveness and adversely affect patient Pacemaker compatibility Only connect items that have been specified aspart of the Temporary Pacemaker or that have been specified as being compatible with thetemporary Pacemaker use The Temporary Pacemaker is not suitable for use in thepresence of a flammable anesthetic mixture with air or with oxygen or nitrous The Temporary Pacemaker is protected from damagecaused by internal defibrillation discharges up to 50 J (watt-seconds) and externaldefibrillation discharges up to 360 J.