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LATITUDE PROGRAMMER – Manual 359487-008

Indications, Safety and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.

Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

Content                             

INTENDED USE/INDICATIONS FOR USE

The LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the PG. For detailed software application instructions, refer to the associated product literature for the PG being interrogated.

CONTRAINDICATIONS

The LATITUDE Programming System is contraindicated for use with any PG other than a Boston Scientific PG. For contraindications for use related to the PG, refer to the associated product literature for the PG being interrogated.The PSA application is contraindicated for use with any programming system other than the Boston Scientific LATITUDE Programming System, Model 3300.The following uses of the PSA are contraindicated: 

  • With AV conduction disorders; atrial single-chamber pacing
  • With competing intrinsic rhythms; asynchronous modes
  • With chronic atrial tachycardia as well as chronic atrial fibrillation or flutter; modes with atrial control (DDD, VDD)
  • With poor tolerance of high ventricular rates (e.g., with angina pectoris); tracking modes (i.e., atrial control modes) and propensity for atrial tachycardia
  • Use as an external pacemaker1

WARNINGS

  • Battery access. When accessing the battery, ensure that power to the Programmer is turned off. Do not touch the connector terminals in the battery compartment while removing or replacing the battery because an electrical charge is present.
  • Electrostatic charges. The PSA lead system is in electrical contact with the patient’s heart and blood.
    • Do not touch the metal clips on the patient cable or the pacing lead. Electrical currents can be dangerous to the patient and the user.
    • Discharge any electrical static charge on your person by touching a grounded metal surface before touching the patient, the patient cables, or the device.
  • Electrical currents. Unused PSA cable connections contacting conductive surfaces can induce electrical currents into the patient’s heart.
    • Attach unused cable connections to surgical draping near the patient or disconnect the unused cables from the system.
  • Electrocautery. The LATITUDE Programming System is designed and tested to be electrocautery safe.
    • While the device is designed and tested to be electrocautery safe, electrocautery can induce electrical currents in the PSA cables that can be conducted into the patient’s heart. However, Boston Scientific recommends that the Programmer be placed as far from the electrocautery system and associated components as possible to minimize noise being introduced into the LATITUDE Programming System and patient cables.
    • Electrocautery may also produce unexpected behavior in the Programmer display or operation. If electrocautery is medically necessary, maintain a distance of at least 30 cm (12 in) between electrocautery equipment and the Programmer and its associated components. Similarly, maintain this distance between the Programmer and its associated components and the patient during these procedures.
    • Do not drape electrocautery components or cables on or near the Programmer or associated cables and components.
    • Whenever possible disconnect the PSA cables from the pacing leads when performing an electrocautery procedure.
    • If the Programmer is connected to the patient during an electrocautery procedure, check its operation afterwards.
    • If the Programmer experiences an issue that causes an error condition, the Programmer will need to be power cycled. During the reset and reboot, which takes up to 90 seconds, there will be no pacing support. For this reason, a backup PSA/pace resource must be available in case electrocautery is applied.
    • The PSA cable must be disconnected from the lead(s) before using external defibrillation.
    • If the Programmer encounters a fault condition, pacing operation continues unless the fault condition was in the PSA component itself. The PSA will not provide pacing support during the reboot of the Programmer to reset the fault condition (which takes up to 90 seconds); therefore, always have external pacing equipment available for patient backup.
    • When the user manually restarts the Programmer, pacing support will be lost. The user must manually reinitiate PSA pacing after the system has completed the self-test. The self-test can take up to 90 seconds.
  • Power up. Do not touch the screen while the Programmer is powering up, as this may cause the area that you touched to become unresponsive when pressed later on.

PRECAUTIONS

General

  • Ensuring a LATITUDE Consult review. In order to ensure a review by Boston Scientific of the patient’s implanted device data, the clinician must call Boston Scientific at 1-800-CARDIAC (227-3422) or contact a local Boston Scientific representative after sending the data to request a LATITUDE Consult review.
  • At all times the institution (clinic) is responsible for the clinical and technical interpretation of LATITUDE Consult reports. The institution acknowledges that if a technical consultation on the data is desired, an institution employee may call 1-800-CARDIAC (227-3422) or contact a local Boston Scientific representative to request a technical review by Boston Scientific. A local Boston Scientific representative may also be notified to assist with technical support of the device.
  • If the institution requests reports to be sent automatically and does not receive a report within 15 minutes of a LATITUDE Consult transmission to Boston Scientific, the institution should call 1-800-CARDIAC (227-3422) or contact a local Boston Scientific representative to receive LATITUDE Consult System status; it is the institution’s responsibility, and not Boston Scientific’s, to ensure that the report is received by the institution.
  • Never touch the electrical contacts on the side panels of the Model 3300 Programmer and the patient, a telemetry wand, or any cable at the same time.
  • Ventricular Sensing. During a PSA session, ventricular sensing behavior is driven by the most recently selected ventricular pacing configuration: RV-only, LV-only, or Bi-V.
  • At system startup, the PSA mode is set to ODO (non-pacing) and the effective ventricular pacing configuration is Bi-V.
  • When a non-pacing mode (ODO or OVO) is selected from the mode palette, sensing is set to Bi-V to ensure sensing is enabled on both leads regardless of any prior configuration.

EMBLEM S-ICD Precautions

For precautions specific to programming the EMBLEM S-ICD pulse generator, refer to the EMBLEM™ S-ICD Application Operator’s Manual (Model 3877).

ADVERSE EFFECTS

The following list includes the possible adverse effects associated with use of the programming system.

  • Arrhythmia (e.g. bradycardia, tachycardia, palpitations)
  • Burns
  • Cardiac Arrest
  • Discomfort
  • Electric Shock
  • Falls
  • Prolonged Procedure
  • Syncope

Any serious incident that occurs in relation to this device should be reported to Boston Scientific and the relevant local regulatory authority.

 92436264 D.4

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