Rehadapt Rehadapter Instructions For Use Manual page 35

A A p p p p e e n n d d i i x x E E
The cable information below is provided for EMC reference
C C a a b b l l e e
DC USB charging
cable
Two switch button
cables
I I m m p p o o r r t t a a n n t t i i n n f f o o r r m m a a t t i i o o n n r r e e g g a a r r d d i i n n g g E E l l e e c c t t r r o o m m a a g g n n e e t t i i c c C C o o m m p p a a t t i i b b i i l l i i t t y y ( ( E E M M C C ) )
This electrical medical equipment needs special precautions regarding EMC and be put into service according
to the EMC information provided in the instructions for use. The equipment conforms to this IEC 60601-1-
2:2014 standard for both immunity and emissions.
This device has the following essential performances:
1. Playback of audio signals transmitted via Bluetooth®.
2. Transmitting input of two wired switches via Bluetooth®.
This device is intended for use in home healthcare and in professional healthcare. Nevertheless, special
precautions need to be observed:
•
W W A A R R N N I I N N G G : : Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
•
W W A A R R N N I I N N G G : : The use of accessories, transducers, and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
•
W W A A R R N N I I N N G G : : Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the Rehadapter™,
including cables specified by the manufacturer. This could result in degradation of the performance
of this equipment.
•
W W A A R R N N I I N N G G : : Should the location of use be near (e.g. less than 1.5 km from) AM, FM, or TV broadcast
antennas, it is necessary to verify if the device is operating normally before use. This is to assure that
the equipment remains safe with regard to electromagnetic disturbances throughout the expected
duration of use.
N N O O T T E E : : For the purpose of its operation, the equipment has wireless communication function. It includes a RF
transmitter and receiver (2.4 GHz, pulse modulation).
N N O O T T E E : : The device is not compatible with high-frequency surgical equipment. Usage or being on standby in the
immediate vicinity of high-frequency surgical devices is prohibited.
N N O O T T E E : : In the case of electrostatic discharge (±15 kV air) and surge voltages (±1 kV), this device can switch off
without causing damage to the device.
G G u u i i d d e e l l i i n n e e s s a a n n d d M M a a n n u u f f a a c c t t u u r r e e r r D D e e c c l l a a r r a a t t i i o o n n
M M a a x x . . c c a a b b l l e e S S h h i i e e l l d d e e d d / / u u n n s s h h i i e e l l d d e e d d
l l e e n n g g t t h h
100 cm Shielded
150 cm Unshielded
N N u u m m b b e e r r
1
2
3 3 5 5
C C a a b b l l e e c c l l a a s s s s i i f f i i c c a a t t i i o o n n
DC power
Signal