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The Solo Pace Control external pulse generator is used with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment by trained personnel. The external pulse generator can be used where short-term demand pacing is indicated for therapeutic purposes. The external pulse generator 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 pacing include, but are not limited to: - · Complete heart block - · Sinus bradycardia - Sick sinus syndrome - · Bradycardia with congestive heart failure - · Cardiac complications during invasive or surgical procedures - · Support, management, and evaluation of a patient before permanent pacemaker implantation - · Support during permanent pacemaker replacement - · Interventional cardiology procedures where pacing is required

The Solo Pace EPG is an AC main powered with battery backup, single chamber, temporary pacemaker designed primarily for interventional cardiology procedures that require controlled pacing. It is a nonsterile component intended to be used outside the sterile field to provide temporary atrial or ventricular pacing as needed during a variety of interventional cardiac procedures. The Solo Pace EPG is bed mountable. It provides assistive operational workflow stages including: (1) pacing capture check; (2) rapid pacing; (3) control pacing; and (4) back-up pacing, which can be set by the physician based upon their preference. The Solo Pace EPG may also be operated in a manual mode, without any assistive modes. The Solo Pace EPG is configured to require the physician to make all clinical decisions (e.g., the presence or absence of contact with pace-able tissue, the presence or absence of 1:1 capture, appropriate conditions for rapid pacing.)

The intended uses of Lifetech Cardio Temporary Pacemaker are 1. to provide temporary single chamber synchronous or asynchronous anti-brady pacing therapy, and 2. to test electrical performance of an implanted lead system, including pacing threshold, sensing sensitivity and impedance. Lifetech Cardio Temporary Pacemaker is only intended to be operated 1. in a clinical setting, and 2. by trained professionals. Indications for anti-brady pacing therapy may be based on symptomatic bradycardia conditions that: 1. results from an acute and reversible cause and will likely not require permanent pacing, and 2. causes symptoms and/or severe hemodynamic impairment and when permanent cardiac pacing is not immediately indicated or available. Examples of specific indications for temporary pacing may include: a) Sick sinus syndrome b) Sinus bradycardia c) Atrial and/or ventricular arrhythmias d) Complete atrioventricular block e) Asystole f) Bradycardia accompanied by congestive heart failure g) Patient support, management and evaluation before the implantation of implantable pacemaker h) Support during the replacement of implantable pacemaker i) Cardiac complications occurring during intervention or surgery j) Support after the cardiac surgery k) Acute myocardial infarction complicated with cardiac conduction block l) High-rate burst pacing for the treatment of supraventricular tachyarrhythmias

The Lifetech Cardio Temporary Pacemaker (hereinafter called "TPM") is a handheld device powered by two common size AA 1.5V Alkaline (LR6) batteries, which is intended for temporary single chamber anti-brady pacing therapy and implanted system analysis. The TPM offers a complete set of pacing and sensing controls and supports either SSI (synchronous) or SOO (asynchronous) pacing modes. Its analysis features enable pacing threshold, sensing sensitivity and impedance measurement.

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. 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 ● - Sinus bradycardia ● - Sick sinus syndrome ● - Bradycardia with congestive heart failure ● - Atrial and/or ventricular arrhythmias ● - Cardiac arrest - o Support, management, and evaluation of a patient prior to permanent pacemaker Implantation - Support during permanent pacemaker replacement ● - 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 treatment ●

The Model 5392 EPG is a battery-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.

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. 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 - Sinus bradycardia - Sick sinus syndrome - Bradycardia with congestive heart failure - Atrial and/or ventricular arrhythmias - Cardiac arrest - Support, management, and evaluation of a patient prior to permanent pacemaker Implantation - Support during permanent pacemaker replacement - 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 treatment

The Model 5392 EPG is a battery-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.

The intended uses of Lifetech Cardio Model 8301 Temporary Pacemaker are 1. to provide temporary single chamber synchronous or asynchronous anti-brady pacing therapy, and 2. to test electrical performance of an implanted lead system, including pacing threshold, sensing sensitivity and impedance. Lifetech Cardio Model 8301 Temporary Pacemaker is only intended to be operated 1. in a clinical setting, and 2. by trained professionals. Indications for anti-brady pacing therapy may be based on symptomatic bradycardia conditions that: 1. results from an acute and reversible cause and will likely not require permanent pacing, and 2. causes symptoms and/or severe hemodynamic impairment and when permanent cardiac pacing is not immediately indicated or available. Examples of specific indications for temporary pacing may include: a) Sick sinus syndrome b) Sinus bradycardia c) Atrial and/or ventricular arrhythmias d) Complete atrioventricular block e) Asystole f) Bradycardia accompanied by congestive heart failure g) Patient support, management and evaluation before the implantable pacemaker h) Support during the replacement of implantable pacemaker i) Cardiac complications occurring during intervention or surgery j) Support after the cardiac surgery k) Acute myocardial infarction complicated with cardiac conduction block

Lifetech Cardio Model 8301 Temporary Pacemaker (hereinafter called "8301 TPM") is a handheld device powered by two common size AA 1.5V Alkaline (LR6) batteries, which is intended for temporary single chamber anti-brady pacing therapy and implanted system analysis. 8301 TPM offers a complete set of pacing and sensing controls and supports either SSI (synchronous) or SOO (asynchronous) pacing modes. Its analysis features enable pacing threshold, sensing sensitivity and impedance measurement. Patient Cable is an accessory provided along with 8301 TPM and is designed to connect a pacing lead system to 8301 TPM.

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. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic 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 - · Sinus bradycardia - Sick sinus syndrome - · Bradycardia with congestive heart failure - · Atrial and/or ventricular arrhythmias - · Cardiac arrest - · Support, management, and evaluation of a patient prior to permanent pacemaker Implantation - · Support during permanent pacemaker replacement - · 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 treatment

The Model 5392 EPG is a batterv-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.

The Medtronic Temporary External Pacemaker 53401 is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. It 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 indications: - Complete heart block - Sinus bradycardia - Sick Sinus Syndrome - Bradycardia with congestive heart failure - Atrial and/or ventricular arrhythmias - Cardiac arrest - Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation - Support during permanent pacemaker replacement - Cardiac complications during invasive or surgical procedures - Temporary support of a patient following cardiac surgery - Acute myocardial infarction complicated by heart block - High-rate burst pacing for the treatment of supraventricular tachyarrhythmias

The Medtronic Temporary External Pacemaker Model 53401 (hereafter simply referred to as the 53401; or the 53401 SC EPG where SC EPG stands for Single Chamber External Pulse Generator) is a battery-powered, single chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The Model 53408 is an optional disposable protective cover to reduce accidental activation of the controls of the 53401 SC EPG.

The Model 53401 SC EPG is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylatic, or diagnostic purposes. Specification indications for temporary cardiac pacing include, but are not limited to, the following indications: - · Complete heart block - · Sinus bradycardia - · Sick Sinus Syndrome - · Bradycardia with congestive heart failure - · Atrial and/or ventricular arrhythmias - · Cardiac arrest - · Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation - · Support during permanent pacemaker replacement - · Cardiac complications during invasive or surgical procedures - · Temporary support of a patient following cardiac surgery - · Acute myocardial infarction complicated by heart block - · High-rate burst pacing for the treatment of supraventricular tachyarrhythmias.

The Medtronic Temporary External Pacemaker Model 53401 (hereafter simply referred to as the 53401; or the 53401 SC EPG where SC EPG stands for Single Chamber External Pulse Generator) is a battery-powered, single chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The Model 53408 is an optional disposable protective cover to reduce accidental activation of the controls of the 53401 SC EPG.

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. 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 - Sinus bradycardia - Sick sinus syndrome - Bradycardia with congestive heart failure - Atrial and/or ventricular arrhythmias - Cardiac arrest - Support, management, and evaluation of a patient prior to permanent pacemaker Implantation - Support during permanent pacemaker replacement - 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 treatment

The Model 5392 EPG is a battery-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.

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. 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 - Sinus bradycardia - Sick sinus syndrome - Bradycardia with congestive heart failure - Atrial and/or ventricular arrhythmias - Cardiac arrest - Support, management, and evaluation of a patient prior to permanent pacemaker Implantation - Support during permanent pacemaker replacement - 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 treatment

The Model 5392 EPG is a battery-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.