Operator’s Manual
3-2
•
Patients undergoing left-sided ablation procedures should be closely monitored
during the post-ablation period for clinical manifestations of infarction.
•
The Steerable Ablation Catheter is intended for single patient use only
.
Do not
reprocess or reuse.
Reuse can cause patient injury and/or the communication of
infectious disease(s) from one patient to another.
•
Catheter entrapment within the heart or blood vessels is a possible complication of
cardiac ablation procedures. The potential for catheter entrapment may be increased
when the Catheter is positioned in the vicinity of the
chordae tendinae
. The occurrence
of this complication may necessitate surgical intervention and/or repair of injured
tissues.
•
The possibility of skin burns to the patient may exist whenever a special high power
catheter is utilized.
•
The use of catheters or cables with unprotected male pin connectors presents a risk of
electrical hazard. Inadvertent attachment of pin connectors to power supply sockets or
connectors could result in electrocution of the patient or operator. Misconnection of
the pins could also lead to inappropriate delivery of RF current through a band
electrode. The users of components with unprotected male pin connectors must
exercise extreme caution during device set-up to prevent patient or operator injury.
Unused pins should be secured so that they do not inadvertantly touch other equipment
or surfaces. Never insert pins into mains outlets or into any equipment other than
systems providing patient electrical isolation in accordance with IEC-601.
•
The APM output labeled recorder must only be connected to a medically isolated
recorder.
•
Grounding reliability can only be acheived when the power supply cord is connected to
a receptacle marked Hospital Only or Hospital Grade.
Precautions
Observe these precautions, before using the System:
•
Careful catheter manipulation must be performed in order to avoid cardiac damage,
perforation, or tamponade. Catheter advancement should be done under fluoroscopic
guidance.
Do not
use excessive force to advance or withdraw the Catheter when
resistance is encountered.
•
The sterile packaging should be inspected prior to use.
•
When using special high power catheters, it is required that two Disposable
Indifferent Patch Electrodes satisfying the requirements of ANSI/AAMI Standard
HF-18 be used as the ablation return electrodes or skin burns may result.
•
It is recommended not to exceed thirty (30) RF power applications per Catheter.
•
The EPT-1000 XP
TM
Cardiac Ablation Controller is intended for use with EP
Technologies Steerable Ablation Catheters and accessories only.
