SJM Confirm
Contents
1. Implantable Cardiac Monitors SJM Confirm Implantable Cardiac Monitor Model DM2102 Product Highlights Accurately detects atrial fibrillation AF and rhythm disturbances Implantable patient activated and automatically activated monitoring system that records subcutaneous ECGs and is indicated in the following cases Patients who have been previously diagnosed with AF or who are susceptible to developing AF Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias Patients who experience transient symptoms that may suggest a cardiac arrhythmia Offers simple to configure data storage options to enable physicians to prioritise data based on individual patient conditions ensuring capture of significant events and to reduce the risk that unexpected events are missed Comprehensive diagnostic data reports from the provide a quick and accurate summary of heart rate assisting physicians in their diagnosis and treatment of the patient s condition The small 6 5 cc size of the SJM Confirm ICM DM2102 is designed to reduce the risk of infection during the implant procedure by requiring a smaller incision and a smaller subcutaneous pocket A small device footprint may also reduce implant time and means less change in body image for patients The proven St Jude Medical SenseAbility feature is designed to allow accurate sensing over a wide range of signals specifically offering m2. potential adverse events ace ST JUDE MEDICAL MORE CONTROL LESS RISK Implantable Cardiac Monitors SJM Confirm Implantable Cardiac Monitor Model DM2102 Product Specifications Model DM2102 Sampling Rate Hz 128 Dimensions mm 56 3 x 18 5x8 Volume cc 6 5 Weight g 12 Electrode Spacing mm 39 Electrode Minimum Surface Area mm 30 PARAMETER SETTINGS Features Longevity 3 years Patient Trigger Yes Auto Activation Trigger Yes Atrial Fibrillation Trigger Yes Programmable AF episode duration gt 30 sec gt 1 min 2 min gt 5 min gt 10 min Tachycardia Trigger Yes Tachycardia Cycle Count Yes Bradycardia Trigger Yes Asystole duration Trigger Yes EGM Storage 48 minutes Patient Trigger Yes Programmable Auto Activation Yes Programmable Activity Response Inhibit Monitor Off Noise Response Inhibit Diagnostics Episodal Diagnostics Yes Heart Rate Histogram Yes Mean Heart Rate No Remote Monitoring Transtelephonic monitoring TTM Patient Activator PA Battery powered PA Model DM2100A Connectivity depends upon country and use of a compatible receiver unit Please contact your St Jude Medical sales representative for more details N wW 0 Customer Support 46 8 474 4756 gt Brief Summary Prior to using these devices please review the Instructions for Use for a complete listing of n y indications contraindications warnings precauti
3. ons potential adverse events and directions for use Devices depicted may not be available in all countries Check with your St Jude Medical representative for product availability UO in your country Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude s Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK Hi _ _ are registered and unregistered trademarks and service marks of St Jude Medical Inc and its related companies S M g 9 2011 St Jude Medical Inc All rights reserved E T UDE E DICAL Item GMCRM898EN MORE CONTROL LESS RISK
4. ore sensitive QRS detection Ordering Information Contents Implantable Cardiac Monitor Model Number Dimensions H x W x T mm Weight g Volume cc DM2102 56 3 x 18 5x8 12 6 5 0 5 Separately Available Accessories Contents SJM Confirm External Patient Activator device Model Number Description DM2100A External Patient Activator Model DM2100A Indications The SJM Confirm ICM is indicated for the monitoring and diagnostic evaluation of patients Adverse Events Possible adverse events in alphabetical order associated with the device include but are who experience unexplained symptoms such as dizziness palpitations chest pain syncope and shortness of not limited to the following Allergic reaction Bleeding Chronic nerve damage Erosion Excessive fibrotic breath as well as patients who are at risk for other cardiac arrhythmias The SJM Confirm ICM Model DM2102 tissue growth Extrusion Formation of hematomas or cysts Infection Keloid formation is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation EUP NRIR RRM abs Hen own contraindications for the implantation of the SJM Confirm ICM However the patient s particular medical condition may dictate whether or not a subcutaneous chronically implanted device can be tolerated Refer to the User s Manual for detailed indications contraindications warnings precautions and
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