BodyGuardian One – Instructions for Use 16
Indications for Use
BodyGuardian One is intended for use by patients who either have or are at risk of having
cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac
disease and require cardiac monitoring on a continuing basis.
Contraindications
BodyGuardian One is NOT intended for use under the following conditions:
• Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
• Patients who the attending physician believes should be hospitalized.
• Infants weighing less than 22 lbs (10 kg).
Precautions
• Use only ECG lead cables provided by Preventice with BodyGuardian One.
• Disconnect ECG lead cable before using a defibrillator.
• When viewing ECG data, the presence of pacemaker signals in the ECG trace should
NOT be considered true representations of the actual pacemaker stimulus amplitude.
Caution: No computerized information is completely reliable, and physicians should
review all ECG results.
• To avoid unintended battery discharge, remove battery from BodyGuardian One when
it will NOT be used for an extended period of time. See Appendix E: Handling
Instructions for Lithium-Ion Battery.
• To receive the best recording results, stay away from heavy electrical equipment or
other sources of electromagnetic interference. Equipment such as electric blankets and
heating pads are included in this group.
• Do NOT expose BodyGuardian One or battery to water or excessive moisture.
• Do NOT expose BodyGuardian One or battery to extreme temperatures beyond the
limits shown in Appendix B: Technical Specifications.
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