Acutus Medical Qubic Force, Техническое руководство

Страница: 13 / 52

11
Safety during Use
WARNING
Risk of electromagnetic interference
The use of this device close to or in direct contact with other devices
should be avoided, as this may lead to the device operating incorrectly.
• Where usage in such a manner is unavoidable, you should monitor
this device and the device or devices being used together with it in
order to check that they are all working correctly.
WARNING
Risk of electromagnetic interference through the use of porta-
ble RF communication devices
If portable RF communication devices (including peripheral devices
such as antenna cables and external antennae) are operated closer than
30 cm (12 inches) from this device, this can result in a reduction in its
performance. This observation also applies even to the specified cable.
• When operating portable RF communication devices (including
peripheral devices such as antenna cables and external antennae),
keep such devices at a distance of at least 30 cm (12 inches) from
this device.
Only operate the device in rooms that fulfill the following conditions:
• No danger of explosion
• Suitable for medical purposes
• Class I power outlet with protective conductor connection
Place the device in a position protected from spray water. Place the device
on a flat, dry surface. Place the device in a position where it cannot slip,
even with cables connected, nor be touched by the patient, and so that you
can pull the power plug out of the device at any time. Make sure that the
ventilation slots remain unobstructed. The device cannot be sterilized and
therefore must not be operated in sterile areas.
The ambient conditions for operation are:
Temperature +10°C ... +40°C
Relative humidity 30% ... 75%, no condensation
Atmospheric pressure 700 ... 1060 hPa
Operation at altitudes Up to 2000 m AMSL
Power supply
The device is operated via the AC voltage (100 to 240 V at 50 / 60 Hz) of a
room used for medical purposes.
CAUTION
Possibility of electric shock
To avoid the risk of electric shock, connect the device only to a power
supply fitted with a PE conductor.
The electrical port must fulfill the following conditions:
• The power outlet fulfills at least the requirements of IEC 60364-7-
710:2002 group 2.
• The device cable feeds directly into a permanently installed socket. No
portable multiple socket outlets may be used.
• When used in combination with other devices, no portable multiple
socket outlets should be used.
• Only power cords which are suitable for medical devices can be used,
such as power cords from Acutus Medical or equivalent power cords
labeled H05VV 3 x 0.75 mm, H05VV 3 x 1 mm, or SJT AWG18.
To disconnect Qubic Force from the mains supply, pull the power plug out
of the device.
Cable and plug connections
WARNING
Allergic reaction
The cable material may trigger allergic reactions in extremely rare cases.
• Prevent the cable from contacting the skin or wounds.
• Replace any cable that shows even slight damage.
• Lay all cables between the patient and the device, as well as within the
measuring apparatus, in such a way that they pose no danger of trip-
ping and that any tensile forces that may occur can be safely buffered.
• Ensure that the contacts of all connector ports and connectors are
clean. Soiled contacts can lead to signal distortions, and thus to false
diagnoses.
• Ensure that there is no condensation on the plugs or in the connector
ports. If condensation is present, dry it before use.
• Do not force the plugs into the connector ports. Do not pull on the ca-
ble when disconnecting the plugs. Rather, release the lock on the plug.