Magnetic Safety

This section provides information about the magnetic fields generated in Vocera Devices. It includes information about their compatibility with implantable devices such as pacemakers and defibrillators.

Vocera Devices enable hands-free voice communication and make use of a speaker to deliver the audio capability. The speaker in the B3000n badge is located at the front of the device, just behind the grill. On the Vocera Smartbadge, it is located on the lower left-side if you are holding the device facing you.

Consistent with the speakers in most audio devices, the speakers in Vocera Devices contain a small magnet that emits a magnetic field. There is a possibility that a clinician wearing a Vocera Device would be caring for a patient fitted with an Adjustable CSF Shunt, which may include an implantable programmable valve. These programmable valves can be affected by magnetic fields. If the Vocera Badge is within 1-2 inches of the implanted device (the Badge and implant site do not have to be physically touching), there is a possibility of impacting the programmed settings in the valve. The field strength of the magnet in B3000n badges is high enough for adjustments in the implantable programmable valve when it is in direct contact with the valve. However, magnetic fields decrease very rapidly with distance.

The following table details the magnetic field strength of the Vocera Devices at various distances from the speaker.

Product	Direct Contact with Speakers	1" (25mm) from Speaker	2" (50mm) from Speaker
B3000n	310 gauss	9.3 gauss	3.7 gauss
V5000	57 gauss	2 gauss	1 gauss
C1000	260 gauss	8.4 gauss	2.8 gauss

All the values with at least 1" (25mm) of distance are well below the indicated level required for adjustment.

Note: To increase the safety of patients fitted with implantable programmable valves like Medtronic StrataTM II valves, Vocera recommends that Vocera Devices are not brought closer than 2" (50mm) to the implanted programmable valve. This recommendation is in line with the guidance provided by Medtronic for their range of StrataTM II valves and the FDA.

Due to the flexibility of the wearable Vocera Devices, it may be worn anywhere in the upper torso area and still preserve audio quality. Clinicians must select the best location that reduces the likelihood that the Vocera Devices come near implanted devices. Possible alternative locations include mounting on the upper arm or close to the clavicle of the wearer. Alternatively, remove the Vocera Devices while in close proximity to a patient with an implantable programmable valve.