Safety Information
Safety Information
25
24
If you use other medical devices or wear implantable medical devices
such as defibrillators or pacemakers and are concerned that your
Miracle-EarLINK
™
Mic+ might cause interference with your medical device,
please contact your physician or the manufacturer of your medical device
for information about the risk of disturbance. The Miracle-EarLINK
™
Mic+
should not be used during an MRI procedure or in a hyperbaric chamber,
or other oxygen-rich environments. The Miracle-EarLINK
™
Mic+ is not
formally certified to operate in explosive atmospheres such as may be
found in coal mines or certain chemical factories.
Use on Aircrafts
The Miracle-EarLINK
™
Mic+ should not be used on aircrafts unless
specifically permitted by the flight personnel.
International Use
The Miracle-EarLINK
™
Mic+ is approved to operate at radio frequencies
that are specific to your country or region and might not be approved for
use outside your country or region.
Be aware that operation during international travel may cause interference
with other electronic devices, or other electronic devices may cause
interference with your Miracle-EarLINK
™
Mic+.
The Miracle-EarLINK
™
Mic+ is designed to the
following temperature ranges:
Operating: -20°C to +60°C (-4°F to 140°F),
relative humidity range 10%-95%
Storage: -40°C to +60°C (-40°F to 140°F)
We are required by regulations to provide the following warnings:
WARNING:
Use of the Miracle-EarLINK
™
Mic+ directly next to
other electronic equipment should be avoided because it could result in
improper performance. If such use is necessary, note as to whether your
hearing aids and the other equipment are operating normally.
WARNING:
Use of accessories, components or replacement parts
other than those provided by the manufacturer of the Miracle-EarLINK
™
Mic+ could result in increased electromagnetic emissions and decreased
electromagnetic immunity and could result in degradation of performance.
WARNING:
If Portable Radio Frequency communications equipment
is used closer than 30 cm (12 inches) from your Miracle-EarLINK
™
Mic+,
degradation of the performance of your hearing aid could result. If this
occurs, move away from the communications equipment.
Although the Miracle-EarLINK
™
Mic+ is not formally certified (IP rated) for
protection against dust or water ingress, per IEC 60529, it has been tested
to the IP 5X level. This means that the Miracle-EarLINK
™
Mic+ is protected
from dust.
The battery in your Miracle-EarLINK
™
Mic+ is not replaceable. Do not
attempt to replace the battery. The Miracle-EarLINK
™
Mic+ does not
contain any user-serviceable parts. Do not open or modify it.
Do not connect the Miracle-EarLINK
™
Mic+ to any devices not described
in this manual. The expected service life of the Miracle-EarLINK
™
Mic+ is
3 years.
Wireless Technical Description
Miracle-EarLINK
™
Mic+ operates in the 2.4- 2.4835 GHz band with a
maximum effective radiated power of 8 dBm with transmission modulation
type of 1M12FXD and 1.1 MHz bandwidth. The receiver section of the radio
has a bandwidth of 2 MHz.
The Miracle-EarLINK
™
Mic+ has been tested to, and has passed, the
following emissions and immunity tests:
• IEC 60601-1-2 radiated and conducted emissions requirements for a
Group 1 Class B device as stated in CISPR 11.
• Harmonic distortion and voltage fluctuations affecting the power
input source as stated in Table 2 of IEC 60601-1-2.
• RF radiated immunity at a field level of 10 V/m between 80 MHz and
2.7 GHz as well as higher field levels from communications devices as
stated in Table 9 of IEC 60601-1-2.
• Immunity to power frequency magnetic fields at a field level of
30 A/m as well as proximity magnetic fields as defined in table 11 of
60601-1-2.
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV
air discharge.
• Immunity to electrical fast transients on the power input at a level of
+/- 2 kV at a 100 Hz repetition rate.
• Immunity to surges on the power input of +/- 1 kV line to line.
• Immunity to conducted disturbances induced by RF fields on the
power input as stated in Table 6 of IEC 60601-1-2.
• Immunity to voltage dips and interruptions on the power input as
stated in Table 6 of IEC 60601-1-2.
10% rH
95% rH
-40
°
C
60
°
C
-20
°
C
60
°
C
