ArtiCure cryoICE cryoSPHERE CRYOS Istruzioni per l'uso - Pagina 2
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Stampa la paginau FORMING THE RIGID REGION OF THE SHAFT TO THE DESIRED SHAPE
The Rigid Region of the Shaft can be formed by hand and supports bending two times with up to the
deflections illustrated in Figure 5.
8) Grasp the Rigid Region of the Shaft with both hands, as illustrated in Figure 5. Avoid applying load in area of
the Shaft Transition.
9) Bend until the desired deflection is achieved, up to the maximum deflections illustrated in Figure 5.
u USING THE PROBE TO PERFORM CRYOABLATION
The PROBE is designed to reach peripheral nerves through an incision sized for an 8mm or larger trocar, after
the trocar has been removed.
The PROBE ablates tissue via cryogenic energy delivered to the Ball Tip. Cryoadhesion of the Ball Tip to tissue
can occur when the PROBE reaches a temperature of 0°C or below. Other portions of the PROBE, including the
Shaft, can become cold, and should be handled with appropriate care.
10) With the PROBE in air, prime the system with a Pre-Freeze cycle: Set the CONSOLE Ablation Timer to 30 seconds
and press the Activation Button to engage Freeze Mode. Wait for the system to cycle through Freeze, Defrost,
and Vent, or manually advance via the Activation Button.
CAUTION: Ensure the CONSOLE is in Ready Mode and the PROBE temperature is above 0°C before contacting tissue,
to avoid unintended cryoadhesion.
11) Set the Ablation Timer to the desired ablation time. The timer is generally set to a default of 120 seconds.
12) Navigate the PROBE to the target ablation site:
a) Identify the target peripheral nerve site.
b) Reach the Ball Tip through an appropriate-sized incision to the target. The probe is designed to fit through
the incision for an 8mm trocar or larger.
c) Under direct visualization, place the Ball Tip against the target tissue.
Do not use excessive force when using the PROBE to avoid tissue damage.
13) Using the Handle, apply gentle pressure to the Ball Tip, and avoid any PROBE movement until after the freeze
cycle completes.
14) Under direct visualization ensure that the probe ball and shaft are not in contact with other anatomical
structures not intended for ablation. An insulative barrier, such as a trocar indicated for thoracic use, may be
used at the incision site to avoid unintended cryoadhesion and/or cryoablation.
Before entering Freeze Mode, always confirm the placement of the Ball Tip is as desired and there is no
undesired tissue contact with the Ball Tip or Shaft, to prevent unintended cryoadhesion and/or cryoablation.
15) Engage Freeze Mode to freeze for the desired length of time. The system will automatically cycle from Freeze to
Defrost after the Ablation Timer has expired.
Intercostal nerve ablations should be at least 2 cm from the dorsal root ganglia or 4 cm
from the base of the spine to prevent damage to the sympathetic chain.
CAUTION: Use care to avoid PROBE movement while cryoadhesion is present, to prevent inadvertent tissue damage.
16) Wait until the PROBE temperature has warmed to above 0°C before attempting to remove the Ball Tip from the
ablation site or moving the Shaft.
CAUTION: Use care while the CONSOLE is in Defrost Mode, as during N
to cause cryoadhesion.
17) After the CONSOLE is in Ready Mode and the PROBE temperature is above 0°C, repeat steps (11) to (15) to create
additional cryoablation lesions.
a) Cryoablations are recommended to be performed 2 levels above the incision(s), at incision(s), and 2 levels
below the incision(s).
If ablating the intercostal nerve, it is not recommended to ablate above the 3rd intercostal space due to the
proximity of the sympathetic trunk or below the 9th intercostal space due to risk of abdominal muscle bulging.
u DISCONNECTING AND DISPOSING OF THE PROBE
18) Close N
O Cylinder by turning the Valve fully clockwise.
2
19) Pull the red N
O Manual Exhaust Knob or press the N
2
depressurize the system.
CAUTION: Ensure the CONSOLE is in Ready Mode before attempting to disconnect the PROBE, to avoid the release of
pressurized N
O gas and possible sudden recoil of the PROBE.
2
20) Disconnect the PROBE from the CONSOLE and discard.
Do not reprocess or reuse the PROBE. Reuse can cause patient injury and/or the communication
of infectious disease(s) from one patient to another.
RETURN OF USED PRODUCT
If for any reason this product must be returned to AtriCure, Inc., a return goods authorization (RGA) number is
required from AtriCure, Inc., prior to shipping. If the product has been in contact with blood or body fluids, it must
be thoroughly cleaned and disinfected before packing. It should be shipped in either the original carton or an
equivalent carton, to prevent damage during shipment; and it should be properly labeled with an RGA number
and an indication of the biohazardous nature of the contents of shipment. Instructions for cleaning and materials,
including appropriate shipping containers, proper labeling, and an RGA number may be obtained from AtriCure, Inc.
DISCLAIMER STATEMENTS
Users assume responsibility for approving the acceptable condition of this product before it is used, and for ensuring
that the product is only used in the manner described in these instructions for use, including, but not limited to,
ensuring that the product is not re-used.
Under no circumstances will AtriCure, Inc. be responsible for any incidental, special or consequential loss, damage,
or expense, which is the result of the deliberate misuse or re-use of this product, including any loss, damage, or
expense which is related to personal injury or damage to property.
WARNING
WARNING
WARNING
O gas venting, the PROBE may cool sufficiently
2
WARNING
O Exhaust Switch on the back of the CONSOLE to fully
2
WARNING
TROUBLESHOOTING
PROBLEM
PROBE does not reach desired
Plugged gas supply path.
defrost temperature after freeze.
PROBE does not reach the proper
Empty or low N
temperature.
Gas not flowing, tubing is
restricted.
Gas leak in PROBE Shaft or tubing.
N
O tank valve closed.
2
CONSOLE displays "---".
Thermocouple Connectors not
fully plugged into the CONSOLE.
PROBE internal wires are broken.
CONSOLE reads positive
Thermocouple Connectors are
temperature during ablation.
plugged in reversed (red-to-
black).
CONSOLE displays fault code, error
See CONSOLE User's Manual.
code, maintenance needed, or low
cylinder pressure light.
SYMBOLS GLOSSARY
SYMBOL
Manufacturer
Do not re-use
Do not use if package is damaged
Not made with natural rubber latex
Catalog number
Caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician
Batch code
Sterilized using irradiation
Refer to instruction manual
Non-pyrogenic
Use-by date
Caution or Warning
Informational note
Temperature limit
Humidity limit
ATRICURE, INC.
7555 Innovation Way
Mason, Ohio 45040 USA
+1 (513) 755-4100
+1 (866) 349-2342
www.AtriCure.com
POTENTIAL CAUSE
SOLUTION
Manually defrost by applying
warm saline to tissue and probe
as necessary.
O cylinder.
Replace low or empty N
2
cylinder.
Verify PROBE tubing is not
pinched.
Replace PROBE.
Fully open N
O tank valve.
2
Plug Thermocouple Connectors all
the way into the CONSOLE ports.
Replace PROBE.
Plug Thermocouple Connectors
into the matching colored
CONSOLE Ports.
MEANING
O
2