13
160-104694 Rev 01
Version 2.2.0
•
Patients with established arrhythmias (i.e., Atrial Fibrillation, PVC’s) should be
carefully monitored for proper synchronization during energy delivery.
•
Adequate precautions should be taken for patients with implantable electrical
devices.
2.4.2 Electrodes
•
To avoid risks of infection for the patient and for the operators, always maintain
the electrodes’ protective packaging (cap, tubes, etc.) when the electrodes are
not placed in the patient.
•
To preserve the electrode’s sterility do not remove the electrodes from the
packaging until the User is ready to apply the electrode to the patient.
•
Do not use the electrodes after the expiration date printed on their packaging.
Observe the electrodes manufacturer’s specific instructions (e.g., printed on the
electrodes’ packaging).
•
Only use AngioDynamics electrode probes with the NanoKnife System
Generator (BF Applied Parts Classification).
•
Maintain electrical separation of the electrodes from safety ground by doing the
following:
a. Disconnect any electrode from the Generator that is not applied to the
patient.
b. Avoid any clamping of the electrode’s cable, unless explicitly instructed or
authorized by the electrode’s manufacturer.
c. Do not connect any devices (e.g., measurement) to the electrodes unless
they have been supplied by and specifically indicated for such a use by the
manufacturer.
2.4.3
Electrocution Hazard
•
Electrocution Hazard! The Generator internally produces voltages that are
dangerous and may be fatal. The Generator does not contain parts serviceable
by the User, and should not be opened.
•
Do not use the Generator in the presence of flammable or explosive gas
mixtures.
•
For electrical safety, the Generator needs grounding. Use only medical level
main power supply cords, e.g., those supplied by the manufacturer.
•
The Generator should be used by trained personnel only.
•
Before plugging the Generator to the main, ensure that the main power cords
are not damaged. Replace them if any damage is noticed—main cords
cannot
be repaired.
•
Do not connect or disconnect the
Generator
from the main power cord with
wet hands.
•
Confirm that the main power cord will be connected to a properly grounded
electrical outlet.
Summary of Contents for NanoKnife
Page 1: ......
Page 6: ...6 160 104694 Rev 01 Version 2 2 0...
Page 16: ...16 160 104694 Rev 01 Version 2 2 0...
Page 26: ...26 160 104694 Rev 01 Version 2 2 0...
Page 30: ...30 160 104694 Rev 01 Version 2 2 0...
Page 42: ...42 160 104694 Rev 01 Version 2 2 0 Three Probe Array Four Probe Array Five Probe Array...
Page 43: ...43 160 104694 Rev 01 Version 2 2 0 Six Probe Array Six Probe Array 10 mm Six Probe Array 15 mm...
Page 70: ...70 160 104694 Rev 01 Version 2 2 0...
Page 78: ...78 160 104694 Rev 01 Version 2 2 0...