Acutus Medical Qubic Force, Technical Manual, Page: 9 / 52

7
Safety during Use
Even when, as pointed out above, the device complies with the
requirements of EN 60601-1-2, strong electromagnetic disturbances may
occur in the immediate vicinity of electrical motors, high-voltage power
lines, PCs, monitors and other – perhaps defective – electrical devices
which may cause the Tare key to be triggered unintentionally and may
sometimes impair the functioning of the device.
This kind of device malfunction should be considered as a possible cause if
the following is observed:
• The values displayed for contact force and application angle are set to
zero with the AcQBlate
®
FORCE ablation catheter connected, as long as
the Tare key has not been pressed.
• The device displays other inexplicable behavior.
Correct operation of the device can be restored with the following
miscellaneous measures:
• Switch off electronic device generating the disturbance.
• Remove the source of interference from the device.
• Switch the device on and off or break the electrical connection be-
tween the device and the source of the interference if this can be done
safely.
If the interference continues, contact Acutus Medical immediately.
WARNING
Risk of electromagnetic interference through the use of unau-
thorized accessories
The use of accessories, transducers or cables not listed by Acutus Medical
or of accessories other than those specified by Acutus Medical, can
produce elevated electromagnetic emissions or cause degradation in the
device’s resistance to electromagnetic interference. Such effects can lead
to the faulty operation of the device.
• Use only accessories authorized by Acutus Medical
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 applies even if using the cables specified by Acutus
Medical, Inc.
• 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.
General Safety Warnings
Risks of improper handling
Disregarding the safety warnings can endanger the patient, the staff and
the equipment.
Note: Failure to observe the safety warnings voids all damage claims and
manufacturer liability.
The following dangers can, for example, arise in the event of improper use:
• Failure of important device functions
• Personal endangerment due to electrical impact
Changes not permitted
Only the manufacturer or a party expressly authorized by Acutus Medical
may perform corrective maintenance, enhancements or modifications to
the device.
Replacement parts and accessories
Use only accessories authorized by Acutus Medical. Using any other parts
voids liability for any consequences, as well as the product guarantee and
warranty.
RF accessories
Use only RF accessories certified according to Standard IEC 60601-2-2.