Product Card
Table Of Contents
- Device Description
- Intended Use
- Indications
- Intended Clinical Benefits
- MRI Safety Information
- Contraindications
- Warnings
- Precautions
- Implantation Procedure
- Device Modification
- Storage and Handling
- Temperature Equilibrium
- Lead Impedance
- Suboptimal Bluetooth Communication
- Disconnecting Leads and Avoiding Shock While Handling
- External Equipment for Arrhythmia Induction
- Antiarrhythmic Drugs
- Sterilization
- Damaged Package
- Environmental Hazards
- Hospital and Medical Environments
- Environmental and Medical Therapy Hazards
- Home and Industrial Environments
- Transcutaneous Electrical Nerve Stimulation
- Radiofrequency Ablation
- Electronic Article Surveillance (EAS)
- Metal Detectors
- Cellular Phones
- Adverse Events
- Pulse Generator Header
- Sensing
- Radiopaque Identification
- Implanting the Pulse Generator
- Managing and Following Patients
- Device Longevity
- Using a Magnet
- Explanting the Pulse Generator
- Out-of-Service/Explant/Patient Death Form
- Technical Support
- Additional Information
- Physical Specifications
- Battery Information
- Device Configurations
- Inductive Communication
- BLE Operating Frequencies
- Spare Parts and Accessories
- Detection Performance in the Presence of Electromagnetic Interference in Differential Mode
- Symbols
37
CAUTION: Setscrews are installed in the pulse generator at the time it is shipped. Exercise
caution when turning the setscrew, which may be backed out of the connector if turned
counterclockwise for more than two rotations.
NOTE: When connecting leads to the pulse generator, make sure that you plug the correct lead
into the correct lead receptacle. For sensing and pacing, this is important to ensure that atrial and
ventricular signals are correctly recorded and that pacing pulses are delivered in the desired
chamber.
CAUTION: When the DF4-LLHH lead receptacle is plugged, disable tachyarrhythmia therapy.
NOTE: For IS4/DF4 leads and lead receptacles, do not use silicone oil, mineral oil, or any
substance other than sterile saline, water, or heparinized saline as a lubricant. For IS-1 leads and
lead receptacles the use of a lubricant is optional.
3. Use and fasten the appropriate lead receptacle plug in an unused lead receptacle. Refer to Spare
Parts and Accessories (page 64) for a list of available lead receptacle plugs.
For dual-chamber and CRT-D devices, if you are not using an atrial sense/pace lead, lubricate and
insert an IS-1 receptacle plug into the receptacle for the atrial sense/pace lead.
For CRT-D devices, if you are not using a left ventricular pacing lead, lubricate and insert an IS-1
plug into the receptacle for the LV lead.
4. Carefully insert the tip of the torque wrench into the setscrew and turn the handle clockwise until