User's Manual
Table Of Contents
- toc
- Additional Technical Information
- Device Description
- Therapies
- Leads
- PRM System
- Related Information
- Indications and Usage
- Contraindications
- WARNINGS
- General
- Labeling knowledge . Read this manual thoroughly before implanta
- For single patient use only . Do not reuse, reprocess, or rester
- Backup defibrillation protection . Always have external defibril
- Resuscitation availability . Ensure that an external defibrillat
- Patch leads . Do not use defibrillation patch leads with the pul
- Separate pulse generator . Do not use this pulse generator with
- Handling
- Avoid shock during handling . Program the pulse generator Tachy
- Do not kink leads . Do not kink, twist, or braid the lead with o
- Handling the lead without Connector Tool . For leads that requir
- Handling the terminal while tunneling . Do not contact any other
- Appropriate lead connections . When implanting a system which us
- Programming and Device Operations
- Post-Implant
- Protected environments . Advise patients to seek medical guidanc
- Magnetic Resonance Imaging (MRI) exposure . Do not expose a pati
- Diathermy . Do not subject a patient with an implanted pulse gen
- Ensure PTM is enabled . If desired, ensure that Patient Triggere
- Magnet Response set to Inhibit Therapy . Once the Patient Trigge
- General
- PRECAUTIONS
- Clinical Considerations
- Sterilization and Storage
- If package is damaged . The blister trays and contents are steri
- If device is dropped . Do not implant a device which has been dr
- Storage temperature and equilibration . Recommended storage temp
- Device storage . Store the pulse generator in a clean area away
- Use by date . Implant the pulse generator and/or lead before or
- Implantation
- Expected benefits . Determine whether the expected device benefi
- Evaluate patient for surgery . There may be additional factors r
- Lead compatibility . Prior to implantation, confirm the lead-to-
- Telemetry wand . Make sure a sterile telemetry wand is available
- Line-powered equipment . Exercise extreme caution if testing lea
- Replacement device . Implanting a replacement device in a subcut
- Do not bend the lead near the lead-header interface . Insert the
- Absence of a lead . The absence of a lead or plug in a lead port
- Electrode connections . Do not insert a lead into the pulse gene
- Defibrillation lead impedance . If total shocking lead impedance
- Shunting energy . Do not allow any object that is electrically c
- Do not suture directly over lead . Do not suture directly over t
- Device Programming
- Device communication . Use only the designated PRM and software
- STAT PACE settings . When a pulse generator is programmed to STA
- Biventricular pacing therapy . This device is intended to provid
- Pacing and sensing margins . Consider lead maturation in your ch
- Proper programming of the lead configuration . If the Lead Confi
- Proper programming of the shock vector . If the shock vector is
- Programming for supraventricular tachyarrhythmias (SVTs) . Deter
- AV Delay . To ensure a high percentage of biventricular pacing,
- Adaptive-rate pacing . Rate Adaptive Pacing should be used with
- Ventricular refractory periods (VRPs) in adaptive-rate pacing .
- Atrial Tachy Response (ATR) . ATR should be programmed to On if
- Threshold test . During a manual LV Threshold test, RV Backup Pa
- Left ventricular pacing only . The clinical effect of LV pacing
- Shock waveform polarity . For IS-1/DF-1 leads, never change the
- Tachy Mode to Off . To prevent inappropriate shocks, ensure that
- Atrial oversensing . Take care to ensure that artifacts from the
- ATR entry count . Exercise care when programming the Entry Count
- ATR exit count . Exercise care when programming the Exit Count t
- Proper programming without an atrial lead . If an atrial lead is
- Left ventricular lead configuration . Proper programming of the
- Left Ventricular Protection Period (LVPP) . Use of a long LVPP r
- Sensing adjustment . Following any sensing range adjustment or a
- Patients hear tones coming from their devices . Patients should
- Patient use of patient triggered monitor . Determine if the pati
- Patient initiate stored EGM . Consider having the patient initia
- Environmental and Medical Therapy Hazards
- Hospital and Medical Environments
- Mechanical ventilators . During mechanical ventilation, respirat
- Conducted electrical current . Any medical equipment, treatment,
- Internal defibrillation . Do not use internal defibrillation pad
- External defibrillation . It can take up to 15 seconds for sensi
- Lithotripsy . Extracorporeal shock wave lithotripsy (ESWL) may c
- Ultrasound energy . Therapeutic ultrasound (e.g., lithotripsy) e
- Electrical interference . Electrical interference or “noise” fro
- Radio frequency (RF) interference . RF signals from devices that
- Central line guidewire insertion . Use caution when inserting gu
- Home and Occupational Environments
- Follow-up Testing
- Explant and Disposal
- Supplemental Precautionary Information
- Potential Adverse Events
- Mechanical Specifications
- Items Included in Package
- Symbols on Packaging
- Characteristics as Shipped
- X-Ray Identifier
- Federal Communications Commission (FCC)
- Pulse Generator Longevity
- Warranty Information
- Product Reliability
- Patient Counseling Information
- Lead Connections
- CAUTION: Prior to implantation, confirm the lead-to-pulse genera
- CAUTION: If the Lead Configuration is programmed to Bipolar when
- Figure 2. Lead connections and setscrew locations, RA: IS-1, RV:
- Figure 3. Lead connections and setscrew locations, RA: IS-1, RV:
- Figure 4. Lead connections and setscrew locations, RA: IS-1, RV:
- Figure 5. Lead connections and setscrew locations, RA: IS-1, RV:
- Figure 6. Lead connections and setscrew locations, RA: IS-1, RV:
- Implanting the Pulse Generator
- CAUTION: The absence of a lead or plug in a lead port may affect
- CAUTION: Do not suture directly over the lead body, as this may
- WARNING: For leads that require the use of a Connector Tool, use
- Table 8. Lead measurements
- WARNING: For leads that require the use of a Connector Tool, use
- WARNING: Do not contact any other portion of the DF4–LLHH or DF4
- WARNING: When implanting a system which uses both a DF4-LLHH/LLH
- CAUTION: For IS-1/DF-1 leads, never change the shock waveform po
- CAUTION: Do not insert a lead into the pulse generator connector
- Figure 7. Inserting the torque wrench
- CAUTION: Insert the lead terminal straight into the lead port. D
- CAUTION: The absence of a lead or plug in a lead port may affect
- CAUTION: To prevent inappropriate shocks, ensure that the pulse
- CAUTION: Take care to ensure that artifacts from the ventricles
- CAUTION: If total shocking lead impedance during implant is less
- CAUTION: Patients should be tested for diaphragmatic stimulation
- CAUTION: To prevent inappropriate shocks, ensure that the pulse
- WARNING: Always have external defibrillation equipment available
- Induce the Patient’s Arrhythmia
- Perform the Induction
- Determine DFT
- Bidirectional Torque Wrench
- Loosening Stuck Setscrews
- Follow Up Testing
- For additional technical reference guides, go to
- Additional Technical Information
• Replacement device. Implanting a replacement device in a subcutaneous pocket that previously housed
a larger device may result in pocket air entrapment, migration, erosion, or insufficient grounding between
the device and tissue. Irrigating the pocket with sterile saline solution decreases the possibility of
pocket air entrapment and insufficient grounding. Suturing the device in place reduces the possibility of
migration and erosion.
• Do not bend the lead near the lead-header interface. Insert the lead terminal straight into the lead
port. Do not bend the lead near the lead-header interface. Improper insertion can cause insulation
or connector damage.
• Absence of a lead. The absence of a lead or plug in a lead port may affect device performance. If a
lead is not used, be sure to properly insert a plug in the unused port, and then tighten the setscrew
onto the plug.
• Electrode connections. Do not insert a lead into the pulse generator connector without taking the
following precautions to ensure proper lead insertion:
• Insert the torque wrench into the preslit depression of the seal plug before inserting the lead into t he
port, to release any trapped fluid or air.
• Visually verify that the setscrew is sufficiently retracted to allow insertion. Use the torque wrench
to loosen the setscrew if necessary.
• Fully insert each lead into its lead port and then tighten the setscrew onto the terminal pin.
•Defibrillation lead impedance. If total shocking lead impedance during implant is less than 20 ,verify
the proximal coil is not in contact with the pulse generator surface. A measurement of less than 20 is
an indication of a short somew here in the system. If repeated measurements show the total shocking
lead impedance is less than 20 , the lead and/or pulse generator may need to be replaced.
• Shunting energy. Do not allow any object that is electrically conductive to come into contact with the
lead or device during induction because it m ay shunt energy, resulting in less energy getting to the
patient, and may damage the implanted system.
9