AtriCure CRYOSP Series Cryo Nerve Block Therapy Instructions
- June 16, 2024
- AtriCure
Table of Contents
- CRYOSP Series Cryo Nerve Block Therapy
- Product Information
- Specifications
- Product Description
- System Description
- Nomenclature
- Indication for Use for Adult Patients
- Indication for Use for Adolescent Patients
- Contraindications
- Q: Can the cryoICE cryoSPHERE+ cryoablation probes be
- Q: What are the environmental specifications for the cryoICE
CRYOSP Series Cryo Nerve Block Therapy
Product Information
Specifications
-
Operational Relative Humidity: 15% to 90%
-
Storage Relative Humidity: 30% to 85%
-
Transit Relative Humidity: 30% to 85%
-
Operational Atmospheric Pressure: 98 to 105kPA (14.2 to 15.2
psi) -
Package Contents: One (1) PROBE, One (1) TOOL
Product Description
The cryoICE cryoSPHERE+ cryoablation probes are designed to
temporarily block pain by ablating peripheral nerves. They work by
freezing the target tissues, creating an inflammatory response
called cryonecrosis. The probes are available in two
configurations: standard length probe shaft (CRYOSP) with an 8mm
ball tip and extended length probe shaft (CRYOSP-L) with an 8mm
ball tip. The flexible region of the shaft can be formed by the
user using the supplied TOOL. The PROBE features a spherical 8mm
cryoablation tip.
System Description
The cryoICE cryoSPHERE+ system consists of the following
components:
-
Single-use cryoICE cryoSPHERE+ cryoablation probe (PROBE) and
forming tool (TOOL) -
AtriCure cryoICE BOX console (CONSOLE) and optional
footswitch -
AtriCure cryoICE BOX components and N2O gas cylinder (not
provided)
Nomenclature
The following nomenclature is used to refer to the features of
the PROBE and TOOL:
-
PROBE FEATURES: [1] Ball Tip, [2] Shaft, [3] Flexible Region,
[4] Rigid Region, [5] Shaft Transition, [6] Handle, [7] Cold Zone
Indicator, [8] Gas Inlet Connector, [9] Gas Exhaust Connector, [10] Thermocouple Connectors, [11] Tubing -
TOOL FEATURES: [12] Barrel, [13] Bending Channel, [14] Insertion Arrow
-
SHAFT FEATURES: [15] Flexible Region, [16] Rigid Region, [17] Cold Zone Indicator, [18] Distal Cold Zone of the Shaft
Product Usage Instructions
Indication for Use for Adult Patients
The cryoICE cryoSPHERE+ cryoablation probes are intended for use
in adult patients to temporarily block pain by ablating peripheral
nerves. This is achieved by freezing the target tissues and
creating an inflammatory response (cryonecrosis).
Indication for Use for Adolescent Patients
The cryoICE cryoSPHERE+ cryoablation probes are intended for use
in adolescent patients of at least 12 years of age. They are used
to temporarily block pain by ablating intercostal nerves under
direct visualization. Direct visualization requires that the
surgeon is able to see the targeted tissue for cryoablation
directly or with assistance from a camera, endoscope, or other
similar optical technology.
Contraindications
There are no known contraindications for the use of cryoICE
cryoSPHERE+ cryoablation probes.
FAQ
Q: Can the cryoICE cryoSPHERE+ cryoablation probes be
re-sterilized and reused?
A: No, the PROBE and TOOL are supplied sterile and non-pyrogenic
in unopened, undamaged packages and are for single-use only. They
should not be re-sterilized or reused.
Q: What are the environmental specifications for the cryoICE
cryoSPHERE+ system?
A: The operational relative humidity should be between 15% to
90%. For storage and transit, the relative humidity should be
between 30% to 85%. The atmospheric pressure should be maintained
between 98 to 105kPA (14.2 to 15.2 psi) during operation.
IFU-0437.A 2023-11 Page 1 of 2
MD
cryoICE® cryoSPHERE+TM cryoablation probe Instructions for Use # CRYOSP; CRYOSP-L
!Caution: Federal Law (US) restricts this device to sale by or on the order of a physician FIGURE 1 PROBE AND TOOL FEATURES
FIGURE 2 CONSOLE OPERATING MODES [a] Ready Mode (green) [b] Freeze Mode (blue)
[c] Defrost Mode (orange)
FIGURE 3 PROBE CONNECTIONS TO CONSOLE
FIGURE 4 RECOMMENDED TOOL USAGE FOR FORMING THE SHAFT FLEXIBLE PORTION
FIGURE 5 SHAFT FEATURES
INDICATION FOR USE FOR ADULT PATIENTS AtriCure’s cryoICE cryoSPHERE+
cryoablation probes are intended for use to temporarily block pain by ablating
peripheral nerves performed by freezing target tissues, creating an
inflammatory response (cryonecrosis).
FOR ADOLESCENT PATIENTS The cryoICE cryoSPHERE+ cryoablation probes are
intended for use to temporarily block pain by ablating intercostal nerves
under direct visualization1 in adolescent patients of at least 12 years of
age.
1Direct visualization, in this context, requires that the surgeon is able to
see the targeted tissue for cryoablation directly or with assistance from a
camera, endoscope or other similar optical technology.
CONTRAINDICATIONS There are no known contraindications.
SYSTEM DESCRIPTION
The AtriCure cryoICE system creates cryoablation lesions in tissue by
delivering a cryogenic Nitrous Oxide (N2O) energy source from the console to
the tip of the connected probe. The system provides controlled lesion forming
temperature that is below 40°C (40°F).
The system is comprised of the following components:
1. Single-use cryoICE 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.
AtriCure cryoICE BOX components and N2O gas cylinder (not provided). PRODUCT
DESCRIPTION
The PROBE is a single-use device offered in two configurations: standard
length probe shaft (CRYOSP) with 8mm ball tip, extended length probe shaft
(CRYOSP-L) with 8mm ball tip. The flexible region of the shaft supports
forming by the user via the supplied TOOL. The PROBE features a spherical 8mm
cryoablation tip. ENVIRONMENTAL SPECIFICATIONS
Operational
Storage
Transit
Temperature: 10ºC/50ºF to 40ºC/104ºF
Temperature: -29°C/ -20°F to 60°C/ 140°F
Temperature: -29°C/ -20°F to 60°C/ 140°F
Relative Humidity: 15% to 90%
Relative Humidity: 30% to 85%
Relative Humidity: 30% to 85%
Atmospheric Pressure: 98 to 105kPA (14.2 to 15.2 psi)
Atmospheric Pressure: N/A
Atmospheric Pressure: N/A
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 [2] Shaft [3] Flexible Region [4] Rigid Region [5] Shaft Transition
[6] Handle [7] Cold Zone Indicator [8] Gas Inlet Connector [9] Gas Exhaust Connector [10] Thermocouple Connectors [11] Tubing
TOOL FEATURES [12] Barrel [13] Bending Channel [14] Insertion Arrow
SHAFT FEATURES (see Figure 5)
[15] Flexible Region [16] Rigid Region [17] Cold Zone Indicator [18] Distal Cold Zone of the Shaft
!WARNING!
Carefully read ALL instructions PRIOR to use. Failure to follow these
instructions, warnings, and cautions may lead to device damage and/or patient
injury.
Carefully read ALL instructions PRIOR to use. Failure to follow CryoICE Box
(ACM) Console Warnings, Cautions, product description, flow rates, and
features may lead to device damage and/or patient injury.
Use of the PROBE should be limited to properly trained and qualified medical
personnel. Failure to provide intended therapy and/ or serious injury could
occur with improper use of this device.
!WARNING!
The ACM components are not suitable for use in the presence of a flammable
anesthetic mixture which can cause a fire or explosion, resulting in user and
patient injury or death.
Care should be exercised in patients with suspected or known allergies or
hypersensitivity to nickel, which is present in small quantities in the PROBE.
The cryoICE cryoSPHERE+ probe contain a small fraction of cobalt which is
considered a substance of concern. Using the PROBE within a radiated field
emitted at frequencies of 810 MHz, 870 MHz, or 930 MHz may degrade measured
temperature signals leading to tissue damage if the probe is prematurely
removed from tissue before the device has defrosted.
DEVICE USE INSTRUCTIONS 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 Flexible
Region of the Shaft or Tubing, as this may pinch or
rupture the gas supply path, preventing the PROBE from properly freezing
and/or defrosting.
! CAUTION: Follow standard guidelines for the safe handling and storage of
high-pressure gas tanks. ! CAUTION: Nitrous Oxide gas must be safely
exhausted. Follow standard hospital guidelines for allowable concentration
levels.
1. Install and power on the CONSOLE and required components. The instructions
for installing and operating the CONSOLE, as well as a technical description
of the system, are detailed in the cryoICE BOXTM User’s Manual. 2. Turn the
N2O Cylinder tank valve fully counterclockwise to open. Verify pressure is at
least 4826 kPa (700 psi) after the appropriate warming period. 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.
!WARNING!
If the sterile package is dropped and/or damaged or the sterile barrier is
breached, discard device and DO NOT USE. Breach of sterile barrier can lead to
infection.
!CAUTION: Ensure the CONSOLE is in READY Mode before attempting to connect the
PROBE. The sudden release of pressurized gas
may cause the PROBE to recoil, which may injure the operator or patient. 4.
With the CONSOLE in READY Mode (see Figure 2), connect the Inlet/Exhaust
Connectors to the CONSOLE Ports as follows (see Figure 3):
a) Insert the blue Gas Inlet Connector into the blue Inlet Port. b) While
pushing back the locking sleeve on the orange Exhaust Port, insert the orange
Gas Exhaust Connector, then release the locking sleeve. c) Verify the Gas
Inlet and Exhaust connectors are engaged by gently tugging on the associated
hoses connectors. d) Insert the red and black Thermocouple Connectors into the
same-colored Thermocouple Ports.
NOTE: When connected correctly, the ACM will display current PROBE
temperature. If not connected, the ACM will display E-H.
FORMING THE FLEXIBLE REGION OF THE SHAFT TO THE DESIRED SHAPE
NOTE: 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.
NOTE: The Flexible Region of the Shaft supports bending up to 140° in one
direction. Successive bends will result in increased bend resistance.
NOTE: Use steady, firm pressure rather than quick, intense force while forming
the Shaft.
NOTE: 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.
!WARNING!
Forming the Flexible Region of the Shaft in any way other than indicated in
the following instructions can damage the PROBE and potentially cause tissue
damage.
Discontinue use immediately if a breach in the PROBE is suspected, to avoid
the release of pressurized N2O gas and injury to the patient or user.
! CAUTION: Do not bend Flexible Region of the Shaft during FREEZE or DEFROST
mode. It can cause a high pressurized gas leak that
can potentially lead to tissue perforation, unintended damage, or injury to
user.
! CAUTION: Do not use the PROBE if damaged as it may result in device
malfunction. Repetitive bends in the same location could
damage the Flexible Region of the Shaft causing device malfunction. The
Flexible Region of PROBE has a limited functional life; if greater than 3
bends are intended, it is recommended to use a second PROBE.
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.
! CAUTION: The Rigid Region of the Shaft should not be bent as it may result
in device malfunction.
USING THE PROBE TO PERFORM CRYOABLATION
NOTE: The PROBE is designed to reach peripheral nerves through an incision
sized for an 8mm or larger trocar, after the trocar has been removed (8mm Ball
Tip). NOTE: 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 (32°F) or below. Other portions of the PROBE,
including the Cold Zone of the Shaft, can become cold, and should be handled
with appropriate care.
8. 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.
a) During the FREEZE cycle, if there are leaks in the blue inlet/orange
exhaust connector, the sound of gas leaking will be heard and/or frost will
appear on the connections. Replace the device before continuing with the
procedure.
!WARNING!
Ensure the CONSOLE is in READY Mode and the PROBE temperature is above 0°C
(32°F) before contacting tissue, to avoid unintended cryoadhesion.
! CAUTION: Do not use the PROBE if damaged as it may result in device
malfunction. The PROBE has a limited functional life; if
greater than 14 Freeze/Defrost cycles are intended, it is recommended to use a
second probe. 9. Set the Ablation Timer to the desired ablation time. The
timer is generally set to a default of 120 seconds. 10. 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 (8mm Ball Tip). c) Under direct
visualization, place the Ball Tip against the target tissue.
!WARNING!
Do not use excessive force when using the PROBE to avoid tissue damage.
11. Using the Handle, apply gentle pressure to the Ball Tip, and avoid any
PROBE movement until after the FREEZE cycle completes.
!WARNING!
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 cold
zone of the Shaft, to prevent unintended cryoadhesion and/or cryoablation.
Avoid direct contact of PROBE with lung to prevent potential risk of
pneumothorax.
Intercostal nerve ablations should be performed 2-4cm lateral to the internal
mammary artery (IMA), to prevent potential damage to the IMA.
If ablating the intercostal nerve for chest wall surgery posterior to mid-
axillary line, 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. 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.
12. Under direct visualization ensure that the probe ball and cold zone of
the shaft are not in contact with other anatomical structures not intended for
ablation. 13. Press the activation button or use the optional ACM footswitch
to engage FREEZE Mode for the desired length of time. The system will
automatically cycle from FREEZE to DEFROST after the Ablation Timer has
expired.
!WARNING!
Use care to avoid PROBE movement while cryoadhesion is present, to prevent
inadvertent tissue damage.
! CAUTION: When using a standard off-the-shelf nerve stimulator, read all of
the manufacturers instructions carefully prior to using
the device. Failure to follow instructions may lead to injury and may result
in improper functioning of the device. 14. Wait until the PROBE temperature
has warmed to above 0°C (32°F) before attempting to remove the Ball Tip from
the ablation site or moving the Cold Zone of the Shaft.
!CAUTION: Use care while the CONSOLE is in DEFROST Mode, as during N2O gas
venting, the PROBE may cool sufficiently to cause
cryoadhesion.
NOTE: If PROBE does not reach desired DEFROST temperature, apply warm,
sterile, saline to the tissue and PROBE area as necessary. 15. After the
CONSOLE is in Ready Mode and the PROBE temperature is above 0°C (32°F), repeat
steps (11) to (14) to create additional cryoablation lesions.
!CAUTION: If the device is subjected to multiple consecutive freeze cycles
(greater than 4), the handle may become colder than
intended, potentially resulting in discomfort for the user’s hand.
DISCONNECTING AND DISPOSING OF THE PROBE 16. Close N2O Cylinder by turning the
Valve fully clockwise. 17. Pull the red N2O Manual Exhaust Knob or press the
N2O Exhaust Switch on the back of the CONSOLE to fully depressurize the
system.
!CAUTION: Ensure the CONSOLE is in Ready Mode before attempting to disconnect
the PROBE. The sudden release of pressurized gas
may cause the PROBE to recoil, which may injure the operator or patient. 18.
Disconnect the PROBE from the CONSOLE and discard.
!WARNING!
FOR SINGLE USE ONLY. DO NOT reuse, reprocess or resterilize. Reuse,
reprocessing or resterilization may compromise the structural integrity of the
device and/or lead to device failure, which in turn may result in patient
injury, illness or death. Reuse, reprocessing or resterilization may also
create a risk of contamination of the device and/or cause patient infection or
cross-infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may lead
to
injury, illness or death of the patient.
DISPOSAL
After use this device should be treated as medical waste and disposed of
following hospital protocol.
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.
IFU-0437.A 2023-11 Page 2 of 2
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.
TROUBLESHOOTING
PROBLEM
PROBE does not reach desired defrost temperature after freeze.
POTENTIAL CAUSE Obstructed gas supply path.
SOLUTION
Manually defrost by applying warm saline to tissue and probe as necessary.
PROBE does not reach the proper temperature.
CONSOLE displays “—“.
Empty or low N2O cylinder. Gas not flowing, tubing is restricted.
Gas leak in PROBE Shaft or tubing.
N2O tank valve closed. Thermocouple Connectors not fully plugged into the
CONSOLE.
Replace low or empty N2O cylinder. Verify PROBE tubing is not pinched.
Replace PROBE.
Fully open N2O tank valve. Plug Thermocouple Connectors all the way into the
CONSOLE ports.
CONSOLE reads positive temperature during ablation.
PROBE internal wires are broken.
Thermocouple Connectors are plugged in reversed (red-to-black).
Replace PROBE.
Plug Thermocouple Connectors into the matching colored CONSOLE Ports.
CONSOLE displays fault code, error code, maintenance needed, or low cylinder pressure light.
See CONSOLE User’s Manual.
CLINICAL STUDY REFERENCES FOR NERVE BLOCK INDICATION
1. Graves C, Idowu O, Lee S, Padilla B and Kim S. Intraoperative
cryoanalgesia for managing pain after the Nuss procedure. J Pediatr Surg.
2017;52:920-924.
2. Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O’Day M and Padilla BE.
Intraoperative intercostal nerve cryoablation during the Nuss procedure
reduces length of stay and opioid requirement: A randomized clinical trial. J
Pediatr Surg. 2019.
3. Harbaugh CM, Johnson KN, Kein CE, Jarboe MD, Hirschl RB, Geiger JD and
Gadepalli SK.vComparing outcomes with thoracic epidural and intercostal nerve
cryoablation after Nuss procedure. J Surg Res. 2018;231:217-223.
4. Keller BA, Kabagambe SK, Becker JC, Chen YJ, Goodman LF, Clark-Wronski JM,
Furukawa K, Stark RA, Rahm AL, Hirose S and Raff GW. Intercostal nerve
cryoablation versus thoracic epidural catheters for postoperative analgesia
following pectus excavatum repair: Preliminary outcomes in twenty-six
cryoablation patients. J Pediatr Surg. 2016;51:2033-2038.
5. Kim S, Idowu O, Palmer B and Lee SH. Use of transthoracic cryoanalgesia
during the Nuss procedure. J Thorac Cardiovasc Surg. 2016;151:887-888.
6. Morikawa N, Laferriere N, Koo S, Johnson S, Woo R and Puapong D.
Cryoanalgesia in Patients Undergoing Nuss Repair of Pectus Excavatum:
Technique Modification and Early Results. J Laparoendosc Adv Surg Tech A.
2018;28:1148-1151.
7. Parrado R, Lee J, McMahon LE, Clay C, Powell J, Kang P, Notrica DM, Ostlie
DJ and Bae JO. The Use of Cryoanalgesia in Minimally Invasive Repair of Pectus
Excavatum: Lessons Learned. J Laparoendosc Adv Surg Tech A. 2019;29:1244-1251.
8. Pilkington M, Harbaugh CM, Hirschl RB, Geiger JD and Gadepalli SK. Use of
Cryoanalgesia for Pain Management for the Modified Ravitch Procedure in
Children. J Pediatr Surg. 2019.
9. Sujka J, Benedict LA, Fraser JD, Aguayo P, Millspaugh DL and St Peter SD.
Outcomes Using Cryoablation for Postoperative Pain Control in Children
Following Minimally Invasive Pectus Excavatum Repair. J Laparoendosc Adv Surg
Tech A. 2018;28:1383-1386.
10. Dekonenko C, Dorman RM, Duran Y, Juang D, Aguayo P, Fraser JD, Oyetunji
TA, Snyder CL, Holcomb GW, Millspaugh DL and St Peter SD. Post-Operative Pain
Control Modalities for Pectus Excavatum Repair: a Prospective Observational
Study of Cryoablation Compared to Results of a Randomized Trial of Epidural Vs
Patient-Controlled Analgesia. J Pediatr Surg. 2019.
11. Zobel MJ, Ewbank C, Mora R, Idowu O, Kim S and Padilla BE. The incidence
of neuropathic pain after intercostal cryoablation during the Nuss procedure.
Pediatr Surg Int. 2019.
EXPLANATION OF SYMBOLS ON PACKAGE LABELING
REFER TO THE OUTER PACKAGE LABEL TO SEE WHICH SYMBOLS APPLY TO THIS PRODUCT.
Caution
Single Sterile Barrier System with protective
packaging outside
Caution: Federal Law (US) restricts this device to sale by or on the order of
a physician
Single Sterile Barrier System with PHT protective packaging inside
Do Not Re-Sterilize
Does not contain Phthalates
Non-Pyrogenic
Waste Electrical and Electronic Equipment
Do Not Use if Package is Damaged
Sterilized using irradiation
Country and Date of Manufacture
US
Manufacturer
Do Not Re-Use
Not made with Natural Rubber Latex
Catalogue Number
Use-by date
Follow instructions for use
Model Number
UDI
Unique Device Identifier
Fragile
Batch code
-20°F (-29°C)
140°F (60°C)
Transit/Storage Temperature limit
85%
%
30% Transit/Storage Humidity limit
Keep Dry
MD
Medical Device
Contains hazardous substances
AtriCure Inc. 7555 Innovation Way Mason, Ohio 45040 USA +1 866 349 2342 +1 513 755 4100