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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 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.