ArtiCure cryoICE cryoSPHERE CRYOS-L Petunjuk Penggunaan

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P001193.B
Instructions for Use
cryoICE® cryoSPHERE™ cryoablation probe
INDICATION FOR USE
AtriCure's cryoICE cryoSPHERE cryoablation probes are sterile, single use devices intended for use in blocking pain by
temporarily ablating peripheral nerves.
The probe may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where
precise peripheral nerve location is desired.
CONTRAINDICATIONS
There are no known contraindications.
SYSTEM DESCRIPTION
The AtriCure cryoICE system creates cryoablation lesions in tissue by delivering a cryogenic Nitrous Oxide (N
energy source from the console to the tip of the connected probe. The system provides controlled lesion forming
temperature that is below –40°C, with typical operating ranges between –50°C to –70°C.
The system is comprised of the following components:
1. Single-use cryoSPHERE cryoablation probe (referred to hereafter as PROBE) and forming tool (referred to
hereafter as TOOL)
2. AtriCure cryoICE BOX (referred to hereafter as CONSOLE) and an optional footswitch
3. N
O gas cylinder (not provided), gas line hose, exhaust hose, and cylinder heater band.
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PRODUCT DESCRIPTION
The PROBE is a single-use device offered in two configurations: standard length probe shaft (CRYOS), and extended
length probe shaft (CRYOS-L). The probe shaft is malleable and supports forming by the user via the supplied TOOL.
The PROBE features a spherical 8mm cryoablation tip.
PACKAGE CONTENTS
1. One (1) PROBE
2. One (1) TOOL
The PROBE and TOOL are supplied STERILE and NON-PYROGENIC in unopened, undamaged package. For single use
only, Do not re-sterilize. Do Not Re-Use.
NOMENCLATURE
This instruction refers to features of the PROBE and TOOL as follows (see Figure 1):
PROBE FEATURES
[1] Ball Tip
[6] Handle
[2] Shaft
[7] Inlet Connector
[3] Flexible Region
[8] Exhaust Connector
[4] Rigid Region
[9] Thermocouple Connectors
[5] Shaft Transition
[10]Tubing
FIGURE 1: PROBE & TOOL FEATURES
Read all instructions carefully prior to using the device. Failure to properly follow instructions
may lead to injury and/or improper device function.
DEVICE USE INSTRUCTIONS
u SETTING UP THE SYSTEM
CAUTION: The PROBE is only compatible with the AtriCure cryoICE BOX. Do not use the PROBE with any other system,
to prevent injury and/or equipment damage.
CAUTION: Do not restrict, kink, clamp, or otherwise damage the Shaft or Tubing, as this may pinch or rupture the gas
supply path, preventing the PROBE from properly freezing and/or defrosting.
1) Install and power on the CONSOLE and required accessories. The instructions for installing and operating the
CONSOLE, as well as a technical description of the system, are detailed in the cryoICE BOX™ User's Manual.
2) Verify the N
O Cylinder pressure is at least 700 PSI after the appropriate warming period.
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3) Examine the device packaging to ensure the sterility of the product has not been compromised. Remove the
PROBE and TOOL from the package per standard sterile technique.
Do not use the PROBE if the package sterile barrier has been breached, to prevent risk of infection.
CAUTION: Ensure the CONSOLE is in Ready Mode before attempting to connect the PROBE, to avoid the release of
pressurized N
O gas.
2
4) With the CONSOLE in Ready Mode (see Figure 2), connect the PROBE Connectors to the CONSOLE Ports as follows
(see Figure 3):
a) Insert the blue Inlet Connector into the blue Inlet Port.
b) While pushing back the locking sleeve on the orange Exhaust Port, insert the orange Exhaust Connector,
then release the locking sleeve.
CRYOS; CRYOS-L
TOOL FEATURES
[11]Barrel
[12]Bending Channel
[13]Insertion Arrow
WARNING
WARNING
c) Verify the Inlet and Exhaust connectors are engaged by gently tugging on the hoses connectors.
d) Insert the red and black Thermocouple Connectors into the same-colored Thermocouple Ports.
Ready Mode (green)
FIGURE 2: CONSOLE ABLATION STATUS INDICATOR
O)
2
u FORMING THE FLEXIBLE REGION OF THE SHAFT TO THE DESIRED SHAPE
The Flexible Region of the Shaft should only be formed using the TOOL, which maintains a safe bending radius
(>1.9 cm) for the Shaft.
The Shaft supports bending up to 180° in one direction. Successive bends will result in increased bend resistance.
Use steady, firm pressure while forming rather than quick, intense force, and discontinue use immediately if a
breach in the PROBE is suspected, to avoid the release of pressurized N₂O gas.
CAUTION: Forming the Shaft in any way other than indicated in the following instructions (e.g. using the forming
tool incorrectly, bending to 180° more than once, bending at the Shaft Transition) can damage the PROBE.
CAUTION: Repetitive bends in the same location could damage the Shaft. If the same bend is desired in a different
plane, do not twist the Shaft; re-straighten the Shaft and create the same bend in the desired plane.
5) Prior to forming, ensure the CONSOLE is in Ready Mode per Figure 2.
6) Insert the PROBE Ball Tip through the TOOL Barrel in the direction of the Insertion Arrow, as illustrated in Figure 4.
7) Rotate the TOOL so the Shaft is rolled into the Bending Channel, as illustrated in Figure 4, until the desired bend
angle is achieved.
FIGURE 4: FORMING THE SHAFT FLEXIBLE PORTION
FIGURE 5: FORMING THE SHAFT RIGID REGION
Freeze Mode (blue)
Defrost Mode (orange)
FIGURE 3: CONSOLE CONNECTIONS
WARNING
ENGLISH