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
• Reviewing c linical events and fault codes
• Reviewing the Arrhythmia Logbook, including stored electrograms (EGMs)
• Reviewing real-time EGMs
• Testing the leads (threshold, amplitude, and impedance)
• Performing a manual capacitor re-formation
• Reviewing respiratory sensor-based diagnostics
• Verifying battery status
• Programming any permanent brady parameter to a new value and then reprogramming it back to t he
desired value
• Programming the Tachy Mode to a new value and then reprogramming it back to the desired value
• Saving all patient data
• Verifying the appropriate final programming prior to allowing the patient to leave the clinic
Transcutaneous Electrical Nerve Stimulation (TENS)
CAUTION: TENS involves passing electrical current through the body, and may interfere with pulse generator
function. If TENS is medically necessary, evaluate the TENS therapy settings for compatibility with the pulse
generator. The following guidelines may reduce the likelihood of interaction:
• Place the TENS electrodes as close together and as far away from the pulse generator and leads
as possible.
• Use the lowest clinically-appropriate TENS energy output.
• Consider cardiac monitoring during TENS use, especially for pacemaker-dependent patients.
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