8
cardiac pacemaker with the main device are expected. Additionally, a safe distance needs to
be maintained between the Bluetooth data receiver and patients with cardiac pacemakers or
other implanted stimulation devices.
It is important to deactivate Continuous Impedance Measurement for all EXG channels in
patients that have a
cardiac pacemaker
or other implanted stimulation devices. Please find a
detailed description regarding this topic in the instruction manual of the DOMINO software, in
the section called
“Continuous impedance measurement”.
If a sensor cable or the device housing itself is damaged do not use it any longer. A risk of
injury due to electrical voltage or thermal energy may occur. The device housing, all wires,
sensor cables and plug connections must be checked for damage before every use.
Damaged
parts
should not be used and must be repaired or replaced by trained experts or by persons
authorized by SOMNOmedics.
When using the 4-channel analogue
optocoupler
to record signals from several external
devices, medical devices and non-medical devices should not be connected at the same time
as there is no galvanic separation between the 4 signal inputs.
The main device is not designed to be used in a potentially explosive or combustible
environment
.
The main device is not designed for outdoor use and thus must be protected against
temperatures below 0°C and above 50°C. Ingression of dust, dirt and water may damage the
device.
Regarding ingression of humidity and water, the main device complies with protection class IP
22. Consequently, the device must be protected against humidity and water.
Should any
liquids
enter the device, the device must be cleaned immediately by
SOMNOmedics customer service personnel. Following this, the device will undergo a safety-
related examination. Do not switch on the device if any liquids have entered.
Cleaning
should only be conducted with a lint-free and damp cloth. Do not use a steam
autoclave.
Please refer to the information about
disinfection
(see chapter 6.1 Cleaning and disinfection).
Adhere to the indicated dosages as well as to the application time. Use disposable protective
gloves when using aggressive disinfectants.
Chemicals required for maintenance have to be stored, prepared and kept ready in appropriate
containers to avoid confusion.
When
stored
for a longer period, the main device should be kept in a closed room to avoid
water condensation caused by temperature fluctuations at high humidity.
Avoid using the main device in close proximity to radio devices, e. g. high frequency operation
devices, wireless (mobile) phones, CB radio devices, microwave ovens etc. where the
electrical field
may exceed 10 V/m (according to norm IEC 60601-1-2).
If a
battery change
is required, only batteries specified by SOMNOmedics may be used.
SOMNOmedics cannot guarantee error-free operation if different batteries are used.