Warranty - St. Jude Medical FlexAbility Bedienungsanleitung

pared, as indicated in step 7. Use care to isolate any unused connector pins of the 1804-S elec-
trogram cable. This will reduce the chances of developing
accidental current pathways to the heart.
2. Inspect the catheter package prior to use. Do not use if the package is open, damaged, or
expired.
3. Remove the catheter from its package. Inspect the electrodes and catheter carefully for integ-
rity and overall
condition.
4. Connect a sterile luer lock syringe filled with saline mix to the luer connection of the catheter.
Push the contents of the syringe into the catheter to confirm all irrigation ports are open.
5. Connect the catheter to the irrigation system using standard luer fittings. The pump must be
able to operate at a minimum injection pressure of 15 psi.
6. Make sure to purge the tubing and catheter of air bubbles before insertion. Flush the catheter
using a high flow pump setting. Add heparin to the saline infusion medium according to the
patient's anticoagulant condition.
7. Connect the 1641 cable to the catheter. Observe connector polarity; do not force connectors or
pin damage can occur. Then connect the 1641 cable to the socket labeled ISOLATED PATIENT
CONNECTOR on the generator front panel.
8. Power ON the generator and initialize the pump. Refer to the Operational Sequence Section of
the RF generator Operator's Manual for a complete description of generator and pump set-up
and communication between the two instruments.
Settings During Ablation Procedure
Irrigation flow rate during ablation
Minimum continuous flow rate
Maximum power setting
Maximum temperature setting
Maximum continuous ablation time at a single
Default Mode
9. Prior to entering ablation parameters in the generator, ensure the indifferent electrode is appro-
priately placed on the patient's body.
10. Set the initial power level to 20 watts.
11. Set the initial temperature to 40°C.
NOTE: Temperature represents the tip electrode temperature only and does not reflect tissue
temperature.
12. Make sure the catheter is in the neutral (straight) position before insertion. An 8.5 F minimum
introducer sheath may be used to aid in insertion. To avoid occlusion of the irrigation conduits,
the catheter must be continuously irrigated when within the vasculature. Irrigation should only
be stopped after removal of the catheter from the body.
13. The catheter should be passed from a peripheral vessel to the desired endocardiac position
with the aid of fluoroscopy.
14. To adjust the curve of the distal tip on the uni-directional catheter, push or pull the thumb con-
trol located on the handle. To adjust the curve of the distal tip on the bi-directional catheter, use
the actuator to deflect the catheter in either direction. Do not pull on the saline luer or connec-
tor.
NOTE: The bi-directional handle has an adjustable tension control knob that allows the
operator to use the actuator and deflectable section in an unlocked state or adjust the tension
to where the actuator and deflectable section are locked in place. The amount of friction
increases as the knob is rotated clockwise until it reaches the fully plus (+) position.
NOTE: The uni-directional handle has an adjustable tension control knob that allows the
operator to use the actuator and deflectable section in an unlocked state or adjust the tension
to where the actuator and deflectable section are locked in place. Out of the package, the knob
will be in the locked position. If necessary, the tension control knob may be rotated to increase
or decrease the tension.
15. Monitor the impedance display on the RF generator, before, during, and after RF power deliv-
ery. If a sudden rise in impedance is noted during RF delivery that does not exceed the preset
limit, manually discontinue the power delivery. Clinically assess the situation. If necessary,
remove the catheter and clean the distal tip to eliminate any coagulum if present.
16. Press the START key on the generator to begin RF therapy (ablation). The pump will automati-
cally increase from basal flow rate to high flow rate.
17. If creating a drag lesion, move the catheter in a linear fashion remaining at one site for no more
than 60 seconds.
18. From the initial power setting (20 watts), power may be increased as needed to the maximum
setting (50 watts) to create an effective lesion. Intracardiac electrograms and impedance
should be assessed prior to changing the power setting. Because there is a possibility of higher
incidences of steam pops at power levels of 40 watts and higher, power should be increased to
these levels only if lower energies do not achieve the intended results.
19. If initial temperature (40°C) is reached but the preset power output is not, it is permissible to
increase the temperature setting to the maximum setting (45°C). Intracardiac electrograms and
impedance should be assessed prior to changing the temperature settings.
20. In case of a steam pop, discontinue RF.
21. In case of a steam pop or automatic shut off, remove the catheter for visual inspection and
check for coagulum, charring, or other catheter defects. Flush the ports prior to reinsertion in
the patient. If the catheter has defects, exchange it for a new one. Relocate the catheter and
attempt another RF application.
22. If the pump alarms and stops the irrigation, immediately remove the catheter from the patient
and inspect and re-flush the catheter (see Generator Operator's Manual and Pump Operator's
Manual). At the end of each ablation period, the pump will automatically return to the baseline
flow rate based on programmed delay.
23. When the procedure is finished, be sure to bring the catheter to its neutral position (straight)
before removing the catheter from the patient.
Connection to Other Equipment
This device may be connected to a commercially available EP recording system using a connection
cable with connectors in the pin configuration corresponding to this catheter. The use of cables with
shrouded pins is recommended and is required in some countries such as the United States. Such
equipment must be "patient isolated," or have an isolated patient cable. Current leakage from the
connected EP recording system must not exceed 10 microamps for intracardiac electrodes.
Specifications for Compatible Generators
Thermometry
Temperature Limit, Maximum
Modes
Minimum Output Power Capability
RF Output Frequency
Impedance Cut-Off
Packaging and Shelf-Life
The catheter packaging is designed to prevent crushing of the product, to minimize product exposure
to the atmosphere, and to provide for aseptic product transfer. It is recommended that the product
remain in the unopened package until time of use. Contents are sterile if the package is unopened and
undamaged. Do not resterilize. Do not use the device if the packaging sterile barrier is open or
damaged. The expiration date is marked on the outside of the package. The product must be stored in
a cool, dry location. The instructions for use are recyclable. Dispose of product and packaging
according to standard solid biohazard waste procedures.

Warranty

St. Jude Medical (SJM) warrants that its products shall be free from defects in materials and
workmanship under normal use. This warranty does not exceed the "Expiration" date stated on any
product labeling. The authorized uses and approved methods of use of each of our products are set
forth in the related "Instructions for Use" that accompany each product. SJM disclaims any
responsibility and liability for the use of its products in a manner that has not been authorized or
approved. SJM's liability under this warranty is limited to replacing its products. The foregoing
warranty excludes and is in lieu of all other warranties whether expressed or implied including, but not
limited to, any implied warranties of merchantability or fitness for a particular purpose. SJM disclaims
any liability for any incidental or consequential loss, damage, or expense directly or indirectly arising
from the use of this product, other than as expressly provided by specific law. SJM neither assumes
nor authorizes any other person to assume for it any other or additional liability for loss, damage, or
expense in connection with this product. For more details please review complete SJM warranty policy
available from SJM or on the back of an SJM invoice.
ARTMT100097718 C (2014-05)
PUMP SETTING
RF GENERATOR SETTING
site
600-999 ml/hr
(10-17 ml/min)
120 ml/hr
(2 ml/min)
50 W
45°C
60 seconds
Temperature Control
Thermocouple
90°C
Temperature Control
50 Watts
485 kHz
High: 300 Ohms / Low: 25 Ohms
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