Safety Considerations
5-4 Clinical and Safety Considerations
Defibrillation Warnings and Cautions
CAUTION Alteration of the factory default setup of the FR2 can affect its performance and should be
performed under the authorization of your Medical Director. Modifications to device operation
resulting from changes to the default settings should be specifically covered in user training.
CAUTION Use only Agilent Technologies-approved data cards. The H
EARTSTREAM FR2 will perform
improperly if non-approved accessories are used.
SAFETY LEVEL POSSIBLE ELECTRICAL INTERFERENCE WITH ECG MONITORING
WARNING Radio-frequency (RF) interference from devices such as cellular phones and two-way
radios can cause improper H
EARTSTREAM FR2 operation. The HEARTSTREAM FR2 should be
used at least 6 feet (2 meters) away from RF devices, as stated in accordance with EN
61000-4-3:1996.
SAFETY LEVEL POSSIBLE IMPROPER DEVICE PERFORMANCE
SAFETY LEVEL POSSIBLE SHOCK HAZARD
WARNING Defibrillation current can cause operator or bystander injury. Do not touch the patient
during defibrillation. Do not allow the defibrillation pads to touch any metal surfaces.
Disconnect the pads connector from the H
EARTSTREAM FR2 before using any other
defibrillator.
SAFETY LEVELS POSSIBLE ECG MISINTERPRETATION
WARNING Do not place the defibrillation pads on the patient’s chest and back (anterior-posterior).
This pad placement can interfere with correct rhythm analysis and shock/no shock
decision. For correct operation, the H
EARTSTREAM FR2 requires that the defibrillation pads
be placed on the chest (anterior-anterior), as shown on the pads.
WARNING For safety reasons, some very low-amplitude or low-frequency heart rhythms may not be
interpreted by the H
EARTSTREAM FR2 as shockable VF rhythms. Also, some VT rhythms
may not be interpreted as shockable rhythms.
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