This guide last modified:
2024-11-06 06:01.
.
This document provides information about the magnetic fields generated and the Wi-Fi technology used 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.
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.
Implantable devices are closely regulated by the FDA and have specific safety standards that they must conform to. The primary standard to which they must conform is IEC60601-1 4th edition. IEC60601-1 covers many aspects of implantable devices, including mechanical, thermal, and electrical safety.
A companion standard, IEC60601-1-2, specifically addresses the immunity of implantable devices to the effects of electromagnetic energy (radio waves). “Immunity” refers to the level of radio frequency energy that the implantable device can be exposed to with no compromises to functionality and safety.
There are a large number of devices that operate in the 2.4GHz spectrum, including Wi-Fi communication products, Bluetooth devices and microwave ovens. Therefore the likelihood of encountering 2.4GHz radio signals in the workplace is very high. This accounts for the higher immunity requirement of 2.4GHz over 5GHz. There are far fewer products that operate in the 5GHz spectrum, Wi-Fi communication products, and radar being the most common.
The Vocera Devices operate at relatively low power levels to extend battery life and limit the area covered by their radio signals.
The Vocera Smartbadges transmit radio signals at the following levels:
The Vocera Minibadge transmit radio signals at the following levels:
The maximum levels of energy emitted by Vocera Device are far below the minimum levels of immunity that implantable devices conforming to IEC60601-1-2 are required to meet and would therefore have no impact on the implantable devices.
This guide last modified:
2024-11-06 06:01.
.