Indications, Safety and Warnings
Indications for Use
The BodyGuardian Holter recorder is a small, portable, digital Holter recorder intended for use by medical professionals to acquire ECG data from a single patient in a clinical, point of care or outpatient setting. ECG data is first recorded to a Secure Digital (SD) card and then transferred to a Holter analysis system for review by a physician or other qualified professional.
- This device captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained medical professional can be useful in determining a diagnosis. However, the data should not be used as sole means for determining a patient’s diagnosis.
- Use of accessories other than those recommended may compromise product performance.
- To maintain designed operator and patient safety, any peripheral equipment and accessories that can come in direct patient contact must be in compliance with IEC 60601-1 and IEC 60601-2-47.
- Hardware is designed to meet or exceed IEC 60601-1-2, however some environmental electrical interference may cause an artifact in the ECG. The quality of ECG signals may be adversely affected by electromagnetic interference from environmental sources resulting in non-physiological waveforms with the potential for misinterpretation.
- This device is not intended for use during an MRI.
- Before performing defibrillation or applying any high frequency surgical equipment to a patient, remove BODYGUARDIAN HOLTER leads and electrodes from the chest area. Cable leads or electrodes trapped under defibrillator pads or paddles during defibrillation or electrodes in contact with high frequency electrosurgical equipment can cause patient burns.
- Once one or more BODYGUARDIAN HOLTER patient leads are connected to a patient, do not allow patient leads to meet with any grounded or live parts. Contact could cause unacceptable levels of electrical current to flow to the patient.
Battery Maintenance and Precautions
- Use only AA Alkaline Batteries (IEC-LR6). Use of another battery may present a risk of short recordings, device damage, or malfunction.
- Remove batteries from BODYGUARDIAN HOLTER unit promptly when depleted.
- Never store a battery in the recorder.