CryoConsole™ 106A3
Operator's Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective
owners.
CryoConsole, Medtronic
Explanation of packaging and product symbols
Refer to the package label and product to see which symbols apply to this product.
Certification to applicable electrical and safety standards.
Vacuum
Defibrillation-proof type CF applied part
Consult instructions for use
Follow instructions for use (blue)
Caution -- consult accompanying documents
Foot switch
Power cord
Cable
Auto connection box
Alternating current
Input
Fuse
Equipotentiality (chassis ground)
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local
regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product.
Volume level (with minimum set point)
Loudspeaker
Synchronization (non-isolated BNC connector)
Temperature limitation
Humidity limitation
Dangerous Goods label for Class 2 Gases: Non-Flammable Non-Toxic
Transit temperature
Storage temperature
Label class 5.1 Gases Oxidizer
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Product documentation
Package contents
CryoConsole
Scavenging hose
Scavenging hose adapter
Y adapter
ECG cable
Electrical umbilical cable
Coaxial umbilical cable
Wrench
Reorder number
Do not resterilize
Do not reuse
Do not freeze
Store above 0°C/32°F
Recycle
Do not use if package is damaged
Lot number
Serial number
Fragile: handle with care
This way up
This side up
Start
Stop current action
USB port
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Network port
Keep dry
Use by
Sterilized using ethylene oxide
Open Here (sterile device)
For US audiences only.
Manufacturer
Conformité Européenne (European Conformity). This symbol means that the device fully complies with
applicable European Union Acts.
Authorized representative in the European community
Electrostatic discharge (ESD) susceptibility
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Contents
Introduction to the CryoConsole ...................................................... 8
Description and intended use .......................................................... 8
Warnings ...................................................................... 8
Precautions .................................................................... 8
Indications ..................................................................... 9
Contraindications ................................................................. 9
Adverse events .................................................................. 9
Safety features ................................................................... 9
The console, its components, and the catheters ............................................... 9
Set up the console for a procedure .................................................... 12
Position the console and lock its wheels .................................................. 12
Open the refrigerant tank valve ........................................................ 13
Connect rear-attaching non-sterile components .............................................. 14
Connect the EP connectivity or BNC cable (optional) ........................................... 15
Power on the console .............................................................. 15
Connect front-attaching non-sterile components ............................................. 16
Connect the sterile electrical umbilical cable ................................................ 18
Connect the sterile coaxial umbilical cable ................................................. 19
Check the refrigerant level ........................................................... 20
Other system connections and controls ................................................... 22
Set up a patient record ............................................................ 22
Select from the main (Home) screen ..................................................... 22
Input the patient’s name ............................................................ 23
Input the patient or hospital ID number (optional) ............................................. 24
Select the patient’s date of birth (optional) ................................................. 24
Select the patient’s gender (optional) .................................................... 24
Select the name of the physician performing the procedure (optional) ................................. 24
Perform cryotherapy ............................................................. 25
Perform a cryoablation procedure with a balloon catheter ........................................ 25
Perform a cryoablation procedure with a focal catheter .......................................... 32
End a procedure ................................................................ 38
Add a diagnosis and outcome (optional) .................................................. 38
Close the patient record ............................................................ 40
Shut down the system ............................................................. 41
Review and download patient records .................................................. 42
Review a patient record on the console screen .............................................. 42
Download a patient record to USB flash drive ............................................... 45
Privacy feature .................................................................. 46
Maintenance .................................................................. 47
Interpret the refrigerant tank gauge reading ................................................. 47
Change the refrigerant tank .......................................................... 47
Use and store the refrigerant ......................................................... 49
Ship the refrigerant tank ............................................................ 49
Clean the console and components ..................................................... 49
Preventive maintenance checks ....................................................... 49
Troubleshooting ................................................................ 50
Work with System Notice messages ..................................................... 50
Download service files to USB flash drive .................................................. 51
List of System Notice messages ....................................................... 52
Troubleshoot the touch screen ........................................................ 55
Troubleshoot refrigerant flow ......................................................... 56
Troubleshoot faulty date readings ...................................................... 56
Technical specifications ........................................................... 56
Environmental parameters ........................................................... 56
Console specifications ............................................................. 56
How supplied .................................................................. 57
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Disposal regulations .............................................................. 57
Console Component Information ..................................................... 57
Manual Retraction Kit .............................................................. 57
Auto Connection Box .............................................................. 63
Coaxial Umbilical Cable ............................................................ 64
Electrical Umbilical Cable ........................................................... 64
Electrocardiogram (ECG) Cable ....................................................... 65
Foot Switch .................................................................... 66
Scavenging Hose ................................................................ 67
Scavenging hose adapter and Y adapters ................................................. 67
Refrigerant Tank ................................................................. 68
Wrench ...................................................................... 69
Power Cord .................................................................... 69
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Introduction to the CryoConsole
Description and intended use
The 106A3 CryoConsole (the console), together with its components and specified catheters, is for use in performing cardiac
ablation procedures. While in CryoAblation mode, the console causes the cooling segments of catheters to reach cryoablation
temperatures sufficient to cause tissue necrosis.
During a procedure, pressurized liquid N2O (nitrous oxide) refrigerant is injected from a tank in the console. The refrigerant travels
through an ultra-fine tube, which passes through the coaxial umbilical cable and the catheter shaft to the cooling segment of the
cryoablation catheter.
Inside the cooling segment of the cryoablation catheter, the liquid refrigerant evaporates as it is released out of the injection tube.
As the liquid evaporates, it absorbs heat from the tissue around the catheter cooling segment, cooling the tissue. The warmed vapor
returns to the console through a lumen within the shaft of the catheter and the coaxial umbilical cable. This lumen is maintained
under a continuous vacuum. The console evacuates the vapor into the hospital suction or evacuation system.
Warnings
These warnings apply in general to using the console for cardiac cryoablation. Refer to the technical manual for console-compatible
catheters for more information related to catheter use.
• Cryoadhesion – Do not pull on the catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, as
this may lead to tissue injury.
• Improper connection – Do not connect a cryoablation catheter to a radiofrequency (RF) generator or use it to deliver RF
energy. Doing this may cause catheter malfunction or patient harm.
• RF ablation – Before powering up an RF generator or applying RF energy, disconnect the cryoablation catheter from the
console to avoid an error message and unnecessary catheter replacement.
Precautions
• Do not resterilize – Do not resterilize a single-use device for purpose of reuse. Resterilization may compromise the structural
integrity of the device or create a risk of contamination from the device that could result in patient injury, illness, or death.
• For single use only – Single-use devices are intended only to be used once for a single patient. Do not reuse or reprocess a
sterile device for purpose of reuse. Reuse or reprocessing may compromise the structural integrity of the device or create a risk
of contamination from the device that could result in patient injury, illness, or death.
• Biohazard disposal – Discard all used catheters and sterile components in accordance with hospital procedures.
• Leakage current from connected devices – Use only isolated equipment (IEC 60601-1 Type CF equipment, or equivalent)
with the console and catheters or patient injury or death may occur. Do not allow leakage current from any connected devices
to the patient to exceed 10 microamperes (µA) under any circumstances.
• System compatibility – Use only Medtronic cryoablation catheters and components and Medtronic-provided refrigerant tanks
with the console. The safety and use of other catheters or components has not been tested.
• Sterile package inspection – Inspect the sterile packaging and catheter prior to use. If the sterile packaging or catheter is
damaged, do not use the catheter. Contact your Medtronic representative.
• Catheter integrity – Do not use a catheter if it is kinked or damaged. If a catheter becomes kinked or damaged while in the
patient, remove it and use a new catheter. Prior to injecting, the physician should ensure that there is no kink in the catheter.
• Required use environment – Cryoablation procedures should be performed only in a fully equipped facility.
• Qualified users – This equipment should be used only by or under the supervision of physicians trained in cryoablation
procedures.
• Electrostatic Discharge (ESD) – The catheter tip and rings provide a low-impedance pathway to the heart. Static electricity
applied to the heart may induce arrhythmia or affect patient health. Therefore, it is recommended that attending health care
professionals discharge static electricity from themselves by touching their skin to a large metal or conductive grounded surface
prior to touching the patient, the cable, and catheters. Also, discharge static electricity from the patient by touching the patient’s
skin in a location away from the catheter.
• ESD susceptibility – Do not touch connector pins or make connections to connectors identified with the ESD susceptibility
symbol, unless ESD precautionary procedures are used. Failure to follow ESD precautionary procedures may cause console
malfunction.
• Fluid incursion – Do not expose a catheter handle or coaxial and electrical connectors to fluids or solvents. If these
components get wet, the cryoablation system may not function properly, and connector integrity may be compromised.
• Cardioversion/defibrillation during ablation procedure – Disconnect the catheter’s electrical connection prior to
cardioversion/defibrillation. Failure to do so may trigger system messages indicating a need for catheter exchange.
• Foot switch location – Make sure to place the foot switch in a location where it will not be stepped on inadvertently to avoid
inappropriately initiating or terminating an injection of refrigerant.
• Electrical safety requirements – The console meets the requirements of IEC 60601-1. It is the user’s responsibility after
installation to verify and ensure that the console meets the applicable local electrical safety requirements.
• Equipment modification – Do not modify this equipment. Modifications may reduce system effectiveness and impact patient
health.
• Nitrous oxide exposure – Minimize exposure to nitrous oxide to prevent short-term behavioral and long-term reproductive
health effects.
• Environmental limits – Perform cryoablation procedures only within the environmental parameters. Operating outside these
parameters may prevent the start or completion of a cryoablation procedure.
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Indications
See the technical manual for the catheter you are using.
Contraindications
See the technical manual for the catheter you are using.
Adverse events
See the technical manual for the catheter you are using.
Safety features
Multiple safety features are built into the console, its components, and the cryoablation catheters.
• A leak detection system prevents the console from starting an injection of refrigerant, or stops an injection that is currently in
progress, if bodily fluid enters into the cryoablation catheter.
• A blood detector stops cryoablation and the vacuum if blood reaches the handle of the cryoablation catheter.
• A fluid detector stops cryoablation and the vacuum if it detects fluid in the console.
• The console verifies the integrity of all connections before enabling cryoablation.
• A pressure relief valve is installed in the cryoablation catheter handle to prevent over-pressurization.
• The console monitors the flow of refrigerant and the return of vapor. Cryoablation is stopped if the flow rate is outside the defined
parameters for the connected catheter.
• The console draws the refrigerant back from the catheter and the coaxial umbilical cable after each injection or if any safety
issues are encountered.
• The cryoablation catheter shaft is kept under continuous negative pressure to ensure that no refrigerant leaks out into the body
in case of a catheter breach.
• For balloon catheters, the double balloon safety system has independent vacuum paths and pressure monitoring in the outer
vacuum path.
The console, its components, and the catheters
The console is intended for use with compatible Medtronic cryoablation catheters. For information about these devices, see their
respective technical manuals.
For information about specific components, see “Console Component Information”, page 57.
For information about setting up the console for a procedure, see “Set up the console for a procedure”, page 12.
The major components of the console and a compatible catheter are shown in Figure 1.
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Figure 1. Major components of the console, shown with a focal catheter
1 Console
2 Touch screen
3 Control panel
4 Front connection panel
5 Auto connection box
6 Catheter handle (sterile component)
7 Catheter shaft (sterile component)
8 Coaxial umbilical cable (sterile component)
9 Electrical umbilical cable (sterile component)
10 ECG cable
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Figure 2. Rear view of the console and components
1 Top rear control panel
2 Lower rear connection panel
3 Foot switch
Figure 3. Console front control panel
1 Green Start button (indicated by
)
2 Stop Current Action button (indicated by )
4 Scavenging hose
5 Power cord
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Figure 4. Console front connection panel
1 Auto connection box cable connector
2 Coaxial umbilical cable connector (with cap unplugged)
Figure 5. Top rear control panel
1 Console power switch
2 EP cable connector
3 USB port
Figure 6. Lower-rear connection panel
1 Foot switch connector
2 Scavenging hose connector
3 Power cord inlet
4 Network connector (inactive)
5 Speaker volume
6 BNC Injection Sync signal output
4 Fuses
5 Equipotentiality (chassis ground)
Set up the console for a procedure
Use the steps in this chapter to prepare the console for a procedure.
Caution: Use only isolated equipment (IEC 60601-1 Type CF equipment, or equivalent) with the console and catheters or patient
injury or death may occur. Do not allow leakage current from any connected devices to the patient to exceed 10 microamperes (µA)
under any circumstances.
Caution: Use only Medtronic cryoablation catheters and components and Medtronic-provided refrigerant tanks with the console.
The safety and use of other catheters or components has not been tested.
Caution: This equipment should be used only by or under the supervision of physicians trained in cryoablation procedures.
Position the console and lock its wheels
1. Position the console in the desired location in the room leaving direct access to the power switch, power cord inlet, and power
cord. The console can be electrically disconnected from the mains by unplugging the power cord or by setting the power switch
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to the OFF position; this is not recommended during a normal procedure. To maneuver and position the console, use the
following pedals:
• The green pedal (labeled with an arrow) locks the swivel wheel in one direction. This makes it easy to roll the console in a
straight line.
• The red pedal (labeled “STOP”) immobilizes the console.
• The gray pedal (labeled “OFF”) releases the other pedals.
Figure 7.
1 Green pedal (labeled with an arrow): Directional lock
2 Red pedal (labeled “STOP”): Brake
3 Gray pedal (labeled “OFF”): Release
2. Once the console is in position, push down both the green pedal and the red pedal, located over each front wheel of the
console, to lock the console wheels.
3. Adjust the screen height and angle using the handles on each side of the screen.
Note: All four wheels of the console have brake pedals, but applying the brakes to the back wheels of the console is required only
if you are storing the console on an incline.
Open the refrigerant tank valve
Open the refrigerant tank valve at least 15 min before the first ablation begins. If the tank has recently been stored below the
recommended operation temperature range, it may take longer to warm up the system.
1. Open the door on the left side of the console by doing the following:
a. Press and release the black knob so it pops out.
b. Turn the knob clockwise and open the door to expose the refrigerant tank.
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2. Open the tank by turning the knob on the top of the tank counter-clockwise.
3. Close the console door.
Connect rear-attaching non-sterile components
Figure 8. Lower connectors on back of console
1 Foot switch connector
2 Scavenging hose connector
3 Power cord inlet
1. If the optional foot switch will be used during the procedure to start and stop injections, plug its cable into the connector.
Caution: When setting up the foot switch, make sure to place it in a location where it will not be inadvertently stepped on.
2. Attach one end of the scavenging hose to the console. If using a purple scavenging hose, tighten it with a wrench. If using any
other scavenging hose, tighten it until it is finger tight. Attach the other end of the scavenging hose to the hospital suction or
evacuation system. (You may need to use an adapter, depending on the type of wall connector at your hospital.)
4 Retainer clip
5 Equipotentiality (chassis ground)
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3. If the power cord is not already attached to the console, lift the retainer clip and hold it in position above the power cord inlet.
Connect the power cord to the power cord inlet. Press down on the retainer clip to hold the power cord securely in position.
4. Ensure the equipotentiality (chassis ground) is connected while performing cryoablation therapy.
Connect the EP connectivity or BNC cable (optional)
Caution: Do not touch connector pins or make connections to connectors identified with the ESD susceptibility symbol, unless ESD
precautionary procedures are used. Failure to follow ESD precautionary procedures may cause console malfunction.
Connect the EP connectivity cable to the serial port on the back of the console for connection to the hospital recording system. The
EP connectivity feature enables cryotherapy information to be transmitted to an EP recording system. Your local representative can
provide more information regarding compatible systems. For additional information, refer to the operator’s manual for the EP
recording system that you are using.
Or,
If used, connect the BNC connectivity cable to the non-isolated Injection Sync BNC connector to the hospital recording system.
The Injection Sync connector provides a signal indicating whether the refrigerant injection is on or off.
On = +.05 V, Off = 0 V
Figure 9.
1 EP connectivity connector – can only be connected to non-isolated input on the hospital EP recording system.
2 BNC Injection Sync signal output – do not insert any other cables into this port
Power on the console
Power on the console at least 15 min before the procedure.
1. Plug the console power cord into a wall outlet.
2. Turn on the power switch located at the back of the console.
Figure 10.
1 Console power switch
The following message appears: System self test - Please Wait…
This self-test verifies that all functions and safety mechanisms are working.
Notes:
• The console will not operate at altitudes above 8000 feet (2400 m).
• If a System Notice appears during this test, refer to “Troubleshooting”, page 50.
• If the touch screen remains black but the console appears to be powered on, refer to “Troubleshoot the touch screen”,
page 55.
When the console has finished the self-test, the Main screen appears, as shown:
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Connect front-attaching non-sterile components
Figure 11.
1 ECG cable connection to the hospital EP recording system
2 Connection to the auto connection box
1. If applicable, connect the cable with 4 shielded-tip connectors to the hospital EP recording system.
2. Connect the other end of the cable to the auto connection box.
3. Connect the auto connection box cable to the left connector on the front of the console, shown in Figure 12.
The end of the cable snaps securely into the console connector and cannot be inadvertently pulled off.
3 Connection to the console
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Figure 12. Auto connection box cable connector
1 Auto connection box cable connector
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Connect the sterile electrical umbilical cable
Figure 13.
1 Catheter connection to the electrical umbilical cable
2 Electrical umbilical cable connection to the catheter
3 Electrical umbilical cable connection to the connection box
1. Connect the cryoablation catheter to the electrical umbilical cable in the sterile field.
2. Connect the other end of the electrical umbilical cable to the connection box.
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Connect the sterile coaxial umbilical cable
Figure 14.
1 Catheter connection to the coaxial umbilical cable
2 Coaxial umbilical cable connection to the catheter
3 Coaxial umbilical cable connection to the console
1. Connect the cryoablation catheter to the coaxial umbilical cable in the sterile field.
2. Pull off the cover from the coaxial connector located on the front of the console, shown in Figure 15.
3. Connect the other end of the coaxial umbilical cable to the coaxial connector. You need to squeeze the prongs together to align
the connector with the holes in the console.
The coaxial cable snaps securely into place.
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Figure 15. Coaxial connector
1 Coaxial connector (unplug cap before connecting)
Check the refrigerant level
Use the following steps to check the amount of refrigerant in the tank.
Note: You should also check the refrigerant level prior to cryotherapy by using the refrigerant gauge on the Therapy tab, as
described in “Perform cryotherapy”, page 25.
1. Open the side door of the console to verify that the refrigerant tank is placed in the center of the load cell inside the console to
promote an accurate reading.
2. On the console touch screen, touch Service System.
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The following screen appears:
3. Check the Tank Level gauge. The amount of refrigerant consumed depends on the catheter and type of procedure used.
4. Touch Return to Main Panel.
If the tank needs to be replaced, see “Change the refrigerant tank”, page 47.
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Other system connections and controls
Other (optional) system connections exist on the console back connection panel:
Figure 16.
1 USB port
2 Network connector (inactive)
Additional information:
USB port – This connection is for use in retrieving data from the console. The appropriate screen for downloading data indicates
when to insert a USB flash drive here. See “Download a patient record to USB flash drive”, page 45
Network connector – Does not provide any functionality or communication.
Speaker volume – Turn the shaft to adjust the volume of auditory system notices and ablation-in-progress tone. The recommended
method for turning off sound is to use the on-screen Mute button for each system notice.
3 Speaker volume
Set up a patient record
Select from the main (Home) screen
1. On the main screen, touch Begin CryoTherapy.
The message “Make sure the refrigerant tank has been opened” appears on the screen.
2. Make sure the refrigerant tank is open.
3. Touch OK.
The following screen appears:
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Notice the 3 tabs at the bottom of the screen. The Patient Info tab has a green dot to show that it is currently selected. As you
complete the procedure, you will use all 3 tabs.
Input the patient’s name
1. Touch the Name box.
A keyboard appears.
2. Enter the patient’s name.
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Do not use any punctuation between the first and last name.
To erase characters to the left, use the << key. To move the cursor to the left or right without erasing, use the < and > keys.
Note: If the name already exists in the database, the system automatically adds a sequence number to it in order to distinguish
between procedures for the same patient. Example: “John Smith-2”.
3. Touch OK.
Note: The patient name is the only information required in order to continue. The other information is optional.
Input the patient or hospital ID number (optional)
1. Touch the ID Number box.
A keyboard appears, as in the previous step.
2. Enter the patient or hospital identification number.
3. Touch OK.
Select the patient’s date of birth (optional)
1. Touch the Date of Birth box.
A Date window appears.
2. Touch the up or down arrows to select the patient’s date of birth.
3. Touch OK.
Select the patient’s gender (optional)
Touch the Male or Female box.
Select the name of the physician performing the procedure (optional)
1. Touch the Physician box.
A list of previously entered physician names appears.
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2. Touch the name of the physician who will be performing the procedure.
Note: To remove a physician’s name from the list, touch the name of the physician and touch Delete. To add a physician’s name
to the list, touch New. In the window that appears, enter the name of the physician on the keyboard and touch OK.
3. Touch OK.
When you have completed the information on the Patient Info tab, you are ready to start the cryotherapy procedure, described in
the next chapter.
Perform cryotherapy
Perform a cryoablation procedure with a balloon catheter
Procedure overview
This is an overview of the ablation procedure using a compatible Medtronic cryoablation catheter. Detailed console operating
instructions begin with “Pre-ablation steps”. Refer to the catheter technical manual for detailed ablation procedure steps.
Note: Ensure that the catheter is connected to the auto connection box prior to inserting the catheter into the patient, in order to
reduce the risk of inadvertent electrostatic discharge (ESD).
Pre-ablation steps
• Place the console in Therapy mode.
• Prepare and insert the steerable sheath into the patient.
• Prepare and insert the catheter into the patient.
Ablation steps
• Set the ablation duration.
• Start the inflation.
• Position the inflated balloon.
• Verify the balloon position.
• Perform cryoablation.
Post-ablation steps
• Review the treatments (optional).
• Remove the catheter from the patient.
Pre-ablation steps
1. Touch the Therapy tab.
A System Notice appears, indicating that the catheter is not inserted into the patient.
2. Click OK in the System Notice message.
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3. Click the Press Here to Enable Vacuum button in the small window. Notice these items on the screen:
• The Therapy tab has a green dot to show that it is currently selected.
• A Balloon Status bar appears to show the current mode as the procedure progresses.
4. Insert the catheter and the steerable sheath into the patient, as described in the catheter technical manual.
• When a temperature of 32°C is reached, a System Integrity Test indicator briefly appears (see Figure 17). Figure 17. During the System Integrity Test
1 Therapy tab
2 Balloon Status bar
• When the System Integrity Test is successfully completed, a System Flush indicator briefly appears. The purpose of the
System Flush is to eliminate remaining humidity in the system by using refrigerant.
You may hear one or more clicks during this time.
3 System Integrity Test indicator
4 Refrigerant gauge (blue=proceed, yellow=refrigerant is
low, red=cannot proceed)
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Figure 18. System Flush
1 System Flush indicator
2 Stop Flush button
Note: If an unanticipated event occurs, the System Flush can be stopped at any time by pressing the Stop Flush button on the
screen, by pressing the Stop Current Action button on the console control panel, or by pushing down on the foot switch.
When the integrity test and system flush are complete, the Balloon Status bar indicates Ready mode, as shown in Figure 19.
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Figure 19. Ready mode
1 Balloon Status bar showing Ready mode
2 Preset ablation duration arrows
5. Check the refrigerant gauge, shown in Figure 19, and change the tank if needed. (For instructions, see “Change the refrigerant
tank”, page 47.)
Ablation steps
1. Set the ablation duration by pressing the up and down arrows, shown in Figure 19.
Note: The default preset ablation duration is determined by the catheter in use. Physicians may modify the preset ablation
duration by using the arrows on the CryoConsole screen. The maximum ablation duration is 480 s.
2. Press the green Start button on the console control panel for two (2) s to inflate the balloon. Alternatively, step on the foot switch
for two (2) s.
Note: If an unanticipated event occurs, the injection of refrigerant can be stopped at any time by pressing the Stop Current
Action button on the console control panel, by pressing the Deflate Balloon button on the screen, or by pushing down on the
foot switch.
Figure 20. Console control panel
1 Green Start button
2 Stop Current Action button
The balloon inflates without cooling; observe the following on the screen, as shown in Figure 21:
• The Balloon Status bar indicates Inflation mode.
• The balloon inflation pressure is displayed as a white line on the system graph.
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• The limit for inflation pressure is displayed as a blue line on the system graph.
• Inflation time increments.
• Total time increments.
Figure 21. Inflation mode
1 Balloon status bar showing Inflation mode
2 Balloon inflation pressure
4 Lower limit for inflation pressure
5 Inflation time
3 Upper limit for inflation pressure
3. Position the inflated balloon at the cryoablation site and verify balloon position, as described in the catheter technical manual.
4. Start cryoablation by pressing the CryoAblation button on the screen.
A green light on the console control panel indicates that refrigerant is flowing.
Warning: Do not pull on the catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, as this may
lead to tissue injury.
Note: If an unanticipated event occurs, the injection of refrigerant can be stopped at any time by pressing the Stop Current
Action button on the console control panel, by pressing the Stop CryoAblation button on the screen, or by pushing down on
the foot switch.
5. Wait for the cryoablation to complete. As the procedure begins and progresses, observe the following on the screen shown in
Figure 22:
• The Stop CryoAblation button appears.
• The Balloon Status bar indicates CryoAblation mode.
• The temperature reading falls.
• The catheter temperature is plotted on the graph.
• The cryotherapy time resets to 0 after inflation is complete, and begins incrementing cryoablation time.
• The total time is incremented.
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Figure 22. CryoAblation mode
1 Stop CryoAblation button
2 Balloon status bar showing CryoAblation mode
3 Temperature
4 Catheter temperature graph
5 CryoTherapy time (shows cryotherapy time not including inflation)
6 Total CryoTherapy time (shows total inflation and cryotherapy time for all treatments in this session)
The system automatically stops the cryoablation at the end of the preset time, and the thawing phase begins.
6. Wait for thawing to complete. Observe the following on the screen, as shown in Figure 23:
• The balloon status bar indicates Thawing mode.
• The word “Thawing” appears in the graph area.
• The temperature reading increases as the balloon thaws.
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Figure 23. Thawing mode
1 Balloon status bar showing Thawing mode
2 “Thawing” displayed in graph area
Note: The balloon deflates automatically when the temperature reaches 20°C. You can force the deflation of the balloon before
the end of the thawing period (before it reaches 20°C) by pressing the Stop Current Action button on the console control panel,
by touching Deflate Balloon on the screen, or by pressing the foot switch. This is not recommended during a normal
procedure.
7. When the thawing phase is complete, the balloon status bar indicates Ready mode, and you can initiate another inflation.
Post-ablation steps
1. If desired, review the treatments by touching the Treatment arrows to move forward and backward among displays of previous
treatments as shown:
3 Temperature reading
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Figure 24. Therapy screen with Treatment arrows
1 Treatment arrows
Note: The system automatically exits Review mode and starts inflating the balloon if you press the green Start button on the
console control panel during Review mode, or if you step on the foot switch. If you disconnect the catheter during Review mode,
the system automatically exits Review mode.
2. Press Exit Review Mode when you have finished reviewing.
3. If desired, perform additional cryoablation treatments as described in “Ablation steps”, page 28.
4. Retract the balloon and remove the catheter from the patient, as described in the catheter technical manual.
Perform a cryoablation procedure with a focal catheter
Procedure overview
This is an overview of the ablation procedure using a Medtronic focal cryoablation catheter. Detailed console operating instructions
begin with “Pre-treatment steps”, page 33. Refer to the catheter technical manual for detailed ablation procedure steps.
Note: Ensure that the catheter is connected to the auto connection box prior to inserting the catheter into the patient, in order to
reduce the risk of inadvertent electrostatic discharge (ESD).
Pre-treatment steps
• Insert the catheter into the patient.
• Place the console in Therapy mode.
CryoMapping steps (for cryoablation catheters with the CryoMapping feature)
• Start refrigerant injection.
• If catheter is correctly positioned, select CryoAblation. Or, stop CryoMapping and reposition catheter.
• If desired, perform additional CryoMapping.
Ablation steps
• Set the ablation duration.
• Perform cryoablation.
• Remove the catheter from the point of cryoablation.
• If desired, perform additional cryoablation treatments.
Post-ablation steps
• Review the treatments (optional).
• If desired, perform additional cryoablation treatments.
• Remove the catheter from the patient.
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Pre-treatment steps
1. Insert the catheter into the patient. (For procedural information, see the catheter technical manual.)
2. Touch the Therapy tab.
Notice that the Therapy tab has a green dot to show that it is currently selected.
3. Click the Press Here to Enable Vacuum button in the small window.
A System Flush indicator briefly appears. The purpose of the System Flush is to eliminate remaining humidity in the system by
using refrigerant. You may hear one or more clicks during this time. Figure 25. System Flush
1 System Flush indicator
2 Stop Flush button
Note: If an unanticipated event occurs, the System Flush can be stopped at any time by pressing the Stop Flush button on the
screen, by pressing the Stop Current Action button on the console control panel, or by pushing down on the foot switch.
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Figure 26. Therapy screen for CryoMapping focal catheter
1 Therapy tab
2 Refrigerant gauge (blue=proceed, yellow=refrigerant is low, red=cannot proceed)
4. Check the refrigerant gauge, shown in Figure 26, and change the tank if needed. (For instructions, see “Change the refrigerant
tank”, page 47.)
CryoMapping steps (for cryoablation catheters with the CryoMapping feature)
Note: To determine whether the CryoMapping feature is available, refer to the technical manual for the compatible Medtronic
catheter that you are using.
1. Verify that the console is in CryoMapping mode by checking that the Mode/CryoMapping button is green on the Therapy
screen. If it is not, press CryoMapping to select the mode.
2. Position the catheter at the cryoablation site, as described in the catheter technical manual.
3. Press the green Start button on the console control panel for two (2) s. Alternatively, step on the foot switch for two (2) s.
A green light on the console control panel indicates refrigerant is flowing.
34
Figure 27. Therapy tab in CryoMapping mode
4. If the catheter is correctly positioned, press the CryoAblation button on the Therapy tab. The treatment clock starts to
increment and the preset values for cryoablation appear. At that point, you may set the ablation duration for cryoablation.
Figure 28. Therapy tab during cryoablation with preset values
Or, press the Stop CryoMapping button on the screen or the red Stop Current Action button on the console control panel to
terminate the injection before the preset time. The preset time and temperature for CryoMapping is a duration of 60 s at −30°C.
35
5. If desired, reposition the catheter, as described in the catheter technical manual, after the console stops displaying a
temperature reading.
6. Perform additional treatments if required.
Ablation steps
You can start cryoablation treatment following a CryoMapping procedure (see steps on “CryoMapping steps (for cryoablation
catheters with the CryoMapping feature)”, page 34).
Or,
You can start a cryoablation treatment directly, without starting in CryoMapping (see steps that follow).
1. Verify that the console is in CryoAblation mode by checking that the Mode/Cryoablation button is green on the Therapy screen.
If it is not, press the Mode/CryoAblation button to select it. Note that if you are using a catheter that does not have the
CryoMapping mode, there are no modes displayed on the screen.
2. Set the ablation duration by pressing the up and down arrows, shown in Figure 29.
Note: The default preset ablation duration is determined by the catheter in use. Physicians may modify the preset ablation
duration by using the arrows on the CryoConsole screen. The maximum ablation duration is 480 s. Figure 29. Ablation duration
1 Ablation duration arrows
3. Position the catheter at the cryoablation site, as described in the catheter technical manual.
4. Press the green Start button on the console control panel for two (2) s. Alternatively, step on the foot switch for two (2) s.
A green light on the console control panel indicates refrigerant is flowing.
Note: If an unanticipated event occurs, the injection of refrigerant can be stopped at any time by pressing the Stop Current
Action button on the console control panel, by pressing the Stop CryoAblation button on the screen, or by pushing down on
the foot switch.
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Figure 30. Console control panel
1 Green Start button used to start injection of refrigerant
2 Stop Current Action button used to interrupt cryoablation at its current point
5. Observe the following on the screen as the procedure begins and progresses (see Figure 31):
• The Stop CryoAblation button appears.
• The cooling segment temperature reading decreases.
• The catheter temperature is plotted on the graph.
• The cryotherapy time is incremented.
• The total time is incremented.
• When the injection stops at the end of the specified time, the temperature reading increases and as soon as it reaches
32°C, the system no longer displays the temperature reading.
Note: The system is designed to automatically block the temperature reading signal when it is not injecting refrigerant. This is
to prevent “noise” on the EP monitoring system.
Figure 31. Cryoablation indicators
1 Stop CryoAblation button
2 Cooling segment temperature
3 Catheter temperature graph
4 CryoTherapy time (resets after each treatment)
5 Total CryoTherapy time (shows total cryotherapy time for all treatments in this session)
6. Wait for the cryoablation to complete.
7. Remove the catheter from the cryoablation site, as described in the catheter technical manual.
37
Warning: Do not pull on the catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, as this may
lead to tissue injury.
8. If desired, perform another cryoablation treatment by repeating the actions in “Ablation steps”, page 36.
Or,
Perform CryoMapping by following the steps in “CryoMapping steps (for cryoablation catheters with the CryoMapping
feature)”, page 34.
Post-ablation steps
1. If desired, review the treatments by touching the Treatment arrows to move forward and backward among displays of previous
treatments, as shown:
Figure 32. Therapy screen with Treatment buttons
1 Treatment arrows
2 Review Mode message
The system goes into Review mode, as indicated on the left side of the screen.
Note: The system automatically starts a cryoablation injection if you press the green Start button on the console control panel
while reviewing treatments, or if you press the foot pedal. If you disconnect the catheter during Review mode, the system
automatically exits Review mode.
2. Press Exit Review Mode when you have finished reviewing.
3. If desired (provided the Therapy tab is still displayed), perform additional cryoablation treatments as described in “Ablation
steps”, page 36.
Or, remove the catheter from the patient as described in the catheter technical manual.
3 Exit Review Mode button
End a procedure
Add a diagnosis and outcome (optional)
1. Touch the Report tab.
The following screen appears. Notice that the Report tab has a green dot to show that it is currently selected. The screen shows
a summary that displays the number of treatments and the treatment time.
Note: The sample screens in this section show information displayed when a balloon catheter has been used. The screens for
focal catheters are the same, except that the summary includes information for cryoablation only (and not inflation).
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Figure 33. Report tab showing focal catheter summary
1 Report tab
2 Number of treatments
2. Touch the Diagnosis box. A list of previously entered diagnoses appears. Figure 34. Report tab with list of diagnoses
3 Treatment time
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Note: To remove a diagnosis from the list, touch the diagnosis and touch Delete. To add a diagnosis to the list, touch New. In
the window that appears, type the new diagnosis and touch OK.
3. Touch a diagnosis and then touch OK.
4. Touch the Outcome box.
A list of previously entered outcomes appears.
Figure 35. Report tab with list of outcomes
Note: To remove an outcome from the list, touch the outcome and touch Delete. To add an outcome to the list, touch New. In
the window that appears, type the new outcome and touch OK.
5. Touch an outcome and then touch OK.
Close the patient record
1. Touch Home in the lower left corner of the screen.
The following message appears on the screen: “Are you sure you want to exit?”
2. To close the patient file, touch Yes. You are no longer able to continue this patient’s procedure without creating a new patient
file.
The main screen appears.
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For information about reviewing the patient data, see “Review and download patient records”, page 42.
Shut down the system
1. On the main screen, touch Shutdown System.
2. Follow the prompts to confirm that you want to shut down, then close the refrigerant tank and replace the cap on the coaxial port,
and confirm those actions when prompted.
3. Touch OK.
The following message appears:
No Input Detected
4. Turn off the power switch on the back of the console.
Note: The console can be electrically disconnected from the mains by unplugging the power cord or by setting the power switch
to the OFF position. This is not recommended during a normal procedure.
5. Disconnect all cables. This is not recommended during a normal procedure.
6. Dispose of single-use components and catheters according to hospital regulations.
7. Carefully store reusable components, as follows:
• Clean components according to hospital regulations.
• Store the auto connection box and ECG cable in the compartment inside the door on the left side of the console.
• On the front connection panel, plug the protective cap into the coaxial umbilical cable connection.
• Wind the scavenging hose and power cord around the cable holders located at the back of the console, as shown:
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Figure 36.
1 Scavenging hose
2 Power cord
Review and download patient records
Review a patient record on the console screen
1. On the main screen, touch Review Patient Records.
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Figure 37. Main screen
If the privacy feature is enabled, enter the password provided by Medtronic. For more information on the privacy feature, see
“Privacy feature”, page 46.
Figure 38. Password screen
The following screen appears. Notice these items on the screen:
• The Patient List tab has a green dot to show that it is currently selected.
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• The left side of the screen lists patients and their treatment dates. (You can use the Patient Name and Date buttons to sort
the list.)
• The right side of the screen shows the details for the selected patient.
Figure 39. Patient Records screen, Patient List tab
1 Patient List tab
2 Patients
2. Select a patient record by touching the patient’s entry in the list.
Note: To delete the selected patient record, touch Delete Record and confirm the deletion when the system asks for
confirmation.
3. Touch the Graphs & Data tab.
The following screen appears. Notice that the Graphs & Data tab has a green dot to show that it is currently selected.
3 Details about selected patient
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Figure 40. Patient Records screen, Graphs & Data tab
1 Graphs & Data tab
2 Treatment arrows
For each treatment that the patient received, there is a screen displaying all of the information that was recorded.
4. Touch the Treatment arrows to move forward and backward among the treatments.
5. If the System Notice button is displayed, touch it to display system messages that appeared during the procedure.
Note: Only System Notices that terminated an injection appear in patient records.
3 Position of the system notice button, when it appears
Download a patient record to USB flash drive
You can save patient data to a USB flash drive. The USB port is on the back of the console. Use only one writable drive at a time.
1. Insert a USB flash drive into the console.
Allow 10-15 s for the media to become operational.
2. Display the record you wish to download.
a. Touch Review Patient Records on the main screen.
Note: If the privacy feature is enabled, enter the password provided by Medtronic. For more information on the privacy
feature, see “Privacy feature”, page 46.
b. Select a patient record by touching the patient’s entry in the list.
3. With the record selected, touch Copy Record.
4. Wait until the system has finished copying the data.
5. Remove the USB flash drive.
Note: In order to ensure the integrity and security of patient health information, it is recommended that you use USB flash drives that
are dedicated to storing console data only.
About a downloaded patient record
The downloaded information contains the patient data, a text file of the injection parameters, and a summary of the case. The data
contains the recorded catheter temperature for each second of the treatment, starting at the beginning of the injection of refrigerant
and ending when the catheter temperature reaches 10°C for focal catheters and 20°C for balloon catheters.
You can load the data from the USB flash drive into a program such as Microsoft Notepad, Word, or Excel (fixed width). You can
import the injection data into a worksheet program (such as Excel) for presentation as a graph.
In the following examples, the data is displayed using Notepad:
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Figure 41. Downloaded patient information
The following example shows a patient summary page, which lists the total number of treatments and the time spent in CryoMapping
and CryoAblation modes:
Figure 42. Patient summary page
Privacy feature
The privacy feature adds password protection to user operations associated with the review of patient files. During initial setup of
the system, if requested, Medtronic will enable the privacy feature and provide you with a password. The password will be the same
as the password that provides the user access to System Settings.
When prompted for a password by the system, use the virtual keyboard to enter the password.
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To enable the privacy feature after initial system setup or to reset the password, contact your local Medtronic representative.
Maintenance
Interpret the refrigerant tank gauge reading
You are able to view the refrigerant gauge on the Therapy tab or the System Setup screen. If refrigerant is low, see “Change the
refrigerant tank”, page 47.
On the Therapy tab:
• If the gauge is blue, there is enough refrigerant to start a procedure.
• If the gauge is yellow, the refrigerant is getting low and you should change the tank before starting the procedure.
Note: If the gauge becomes yellow during a procedure, you can continue the procedure, but you must replace the tank at the
end of the procedure.
• If the gauge is red, the system will not allow any more injections of refrigerant until you change the tank. (A System Notice window
appears and the system sounds a tone to warn you.)
On the System Setup screen:
The gauge indicates tank fullness based on weight. Note that a full tank contains 10 lb (4.5 kg) of refrigerant.
Change the refrigerant tank
The console holds one tank of refrigerant at a time. To change the tank, you need the following:
• A full refrigerant tank supplied by Medtronic.
• A 1-1/8 in (28.6 mm) open-ended wrench (supplied with the console)
Caution: Use only Medtronic cryoablation catheters and components and Medtronic-provided refrigerant tanks with the console.
The safety and use of other catheters or components has not been tested.
Close and remove the existing tank
1. Turn off the console (recommended).
2. Open the door on the left side of the console by doing the following:
a. Press and release the black knob so it pops out.
b. Turn the knob clockwise and open the door.
3. Close the refrigerant tank by turning the knob on the top of the tank clockwise.
4. Fit the end of the wrench over the nut and rotate the wrench counterclockwise to loosen the nut.
5. Unscrew the nut until you can separate the tank from the tubing.
6. Remove the black safety belt from the tank and lift the tank out of the console.
Connect the full refrigerant tank
1. Gently place the full tank on the load cell in the console. Verify that you have placed it in the center of the load cell to promote
an accurate reading.
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Note: The load cell contains electronics that measure the weight of the tank to determine how much refrigerant remains.
2. Attach the black safety belt.
3. Fit the nut on the end of the tubing over the fitting on the tank.
4. Tighten the nut with your fingers.
5. Fit the wrench over the nut and turn clockwise until it is tight.
Note: The hose must remain in a vertical position.
Check for leakage
1. Turn the knob on top of the tank counterclockwise to open the tank.
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2. If you suspect leakage, use liquid detector solution (water and soap) on the connection to ensure that no gas is escaping.
3. Tighten the connection again as required.
Caution: Minimize exposure to nitrous oxide to prevent short-term behavioral and long-term reproductive health effects.
Note: If the leak persists, contact Technical Support.
4. Close the console door.
Use and store the refrigerant
The console operates with a refrigerant tank that contains high-pressure liquid nitrous oxide (N2O). Consider the following when
storing and using the refrigerant tanks:
• Store and handle the refrigerant tanks according to the hospital gas management policy.
• Use only Medtronic cryoablation catheters, refrigerant tanks, and components with the console. The safety and use of other
catheters or components has not been tested.
• Do not use Medtronic refrigerant tanks on anesthetic equipment.
• Do not open the tank valve until it is properly connected to the console.
• You can vent nitrous oxide through the hospital scavenging or evacuation system.
• Do not kink the scavenging hose or in any way restrict the exhaust flow.
• Do not disconnect the catheter or the scavenging hose from the console until all nitrous oxide is vented from the system (a few
seconds after the end of the last injection).
• The Threshold Limit Value (TLV) for nitrous oxide is 25 ppm as recommended by the National Institute for Occupational Safety
and Health (NIOSH).
Ship the refrigerant tank
If you need to ship the refrigerant tank to another site, you must adhere to all local transportation laws for dangerous goods.
Clean the console and components
Use isopropyl alcohol to wipe the exterior surfaces of the console and other non-sterile components. Use a screen cleaner for the
touch screen.
Never clean and reuse sterile components.
Caution: Discard all used catheters and sterile components in accordance with hospital procedures.
Preventive maintenance checks
Medtronic suggests that the console undergo a preventive maintenance check at least once per year. To schedule this, contact your
Medtronic representative.
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Troubleshooting
Work with System Notice messages
Figure 43.
1 Problem
2 Action
3 Scroll arrows (appear when there are multiple messages)
4 Mute button
System Notice messages appear in order of severity from high to low, and are color-coded as follows:
• Red = Urgent warning
• Orange = Warning
• Yellow = Caution
• Blue = Notice/Information
If a System Notice message appears, do the following:
• Carefully read and follow the instructions in the window.
• If there are multiple messages, touch the arrows to scroll through the messages.
• To stop the beeping that can occur with some System Notice messages, touch the Mute button.
• If you need to call CryoCath Technical Support for help, make note of the System Notice message number.
• Touch Continue to close the System Notice window so that you can try another injection.
• If advised to do so by a system message, touch Reboot to shut down and restart the system.
Redisplay a System Notice message
If you need to redisplay a System Notice message (because you forgot to note the number, for example) follow these steps:
1. From the main screen, touch Review Patient Records.
2. Select the patient record by touching the patient entry in the list.
3. Touch the Graphs & Data tab.
The following screen appears:
5 System Notice message number
6 Reboot button (click only if instructed to do so by a system
message)
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Figure 44. Patient Records screen, Graphs & Data tab
1 Treatment arrows
2 Position of the System Notice button, when it appears
4. Touch the Treatment arrows to move forward and backward among the treatments until you find the treatment in which the
System Notice was displayed.
5. Touch System Notice.
Note: Only System Notices that terminated an injection appear in patient records.
Download service files to USB flash drive
You can download files containing system data to a USB flash drive for Medtronic’s use in troubleshooting a problem with the
console. Use these steps:
1. Insert a USB flash drive into the console.
Allow 10-15 s for the media to become operational.
2. On the main screen, touch Review Patient Records.
Note: If the privacy feature is enabled, enter the password provided by Medtronic. For more information on the privacy feature,
see “Privacy feature”, page 46.
3. Select a patient record by touching the patient entry in the list.
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Figure 45. Patient Records screen, Patient List tab
4. Touch Copy Service Files to Disk.
5. Wait until the system has finished copying the data.
6. Remove the USB flash drive.
Notes:
• Service files are not readable by non-Medtronic personnel.
• For confidentiality, the service files do not contain any patient names or identification.
List of System Notice messages
System
Notice
Number Problem Action
11200 There is a problem with the system
12201 Electrical system not initialized. Reset system by disconnecting the electrical umbilical cable
12202 There is a problem with the system file. Report the System Notice number to CryoCath Technical Sup-
12203 There is a problem with the failure storage file. Report the System Notice number to CryoCath Technical Sup-
12204 There is a problem with the operational parame-
12206 The catheter may be outside the patient. The
12207
12208
Error1: x - x - x
Error2: x - x - x
(For example:
Error1: 1b - 0 - 0
Error2: 0 - 0 - 0)
ters file.
catheter tip temperature must be within 5°C of
normal body temperature.
Electrical system not initialized. Reset the system by disconnecting the electrical umbilical
Note the error codes. Shut down the system and restart it.
Ensure no catheter is connected during the power up. If the
problem persists, contact CryoCath Technical Support.
from the catheter and reconnecting it. If the problem persists,
report the System Notice number to CryoCath Technical Support.
port.
port.
Before taking any action, contact CryoCath Technical Support.
Confirm catheter is inside the patient and check the electrical
connections. If the problem persists, replace the auto connection box. If the problem still persists, replace the electrical
umbilical before replacing the catheter.
cable from the catheter and reconnecting it. If the problem per-
52
System
Notice
Number Problem Action
sists, report the System Notice number to CryoCath Technical
Support.
12209
12210
12211
12212
12213
12214
12216
12217
12215 The system does not recognize the catheter. Reset system by disconnecting the electrical umbilical cable
12218 The safety system has detected a compromised
12219 The system has detected a temperature drop
12220 The system is unable to initiate System Flush. Press “Continue” to try again. If the problem persists, shut down
12221 The system has detected a high level of refriger-
12222 The system detected a refrigerant leak during
12320 The patient name field is empty. Enter the patient’s name in order to continue.
14301 The system drive is almost full. Free some space on the drive before the next procedure.
18300 The system has detected a malfunction prevent-
20306 File operation error.
21200 System self test did not pass. Shut down the system and restart it. Ensure no catheter is con-
22405 The balloon is not sufficiently inflated. Ensure the tank is open and repeat inflation. Try again. If the
22406 The balloon is deflated. Repeat inflation. If the problem persists, replace the coaxial
22409 File copy File transfer complete.
23300 Are you sure you want to exit? Exiting will close the patient file. As a result, you will not be able
23302 Are you sure you want to Reboot? Pressing “Yes” will return to the Main Screen and remove
23400 File Delete Are you sure you want to delete the file permanently?
24301 No USB drive detected. To continue, connect your USB drive and press “OK”. Other-
50000 The electrical umbilical cable is not connected
50001 The vacuum is disabled due to a problem with the
The time usage limit allowed for the catheter has
expired. The current time is more than 12 hours
past the time of the first injection performed with
this catheter.
The system does not recognize the catheter. Reset the system by disconnecting the catheter umbilical cable
outer vacuum.
during the System Flush. System Flush has been
stopped.
ant flow during System Flush. System Flush has
been stopped.
balloon inflation.
ing further delivery of cryotherapy.
Insufficient space.
properly.
coaxial umbilical cable.
Replace the catheter.
and reconnecting it. If the problem persists, replace the electrical umbilical. If there is still a problem, check the connection
box or replace the catheter.
from the catheter and reconnecting it. If the problem persists,
replace the catheter.
Reset the system by disconnecting the electrical umbilical
cable from the catheter and reconnecting it. If the problem persists, replace the catheter.
Press “Continue” to try again. If the problem persists, shut down
the system and restart it. If there is still a problem, report the
System Notice number to Technical Support.
the system and restart it. If there is still a problem, report the
System Notice number to Technical Support.
Press “Continue” to try again. Disconnect and reconnect the
coaxial umbilical cable. If the problem persists, replace the
coaxial umbilical. If the problem still persists, report the System
Notice number to Technical Support.
The system will operate correctly but should be serviced.
Shut down the system and restart it. Ensure no catheter is connected during the power up. If the problem persists, contact
CryoCath Technical Support.
Insert another USB drive and press “OK”. Try again.
nected during the power up. If the problem persists, contact
CryoCath Technical Support.
problem persists, replace the catheter.
umbilical cable before replacing the catheter. If the problem still
persists, report the System Notice number to CryoCath Technical Support.
to continue this patient’s procedure and will have to create a
new patient file.
access to the therapy module. The system will then have to be
shut down and then restarted. Press “No” if you wish to attempt
to resolve the problem and continue the procedure.
wise, press “Cancel”.
Disconnect both ends of the electrical umbilical cable and
reconnect them.
Disconnect both ends of the coaxial umbilical cable and recon-
nect them. If the problem persists, report the System Notice
number to CryoCath Technical Support.
53
System
Notice
Number Problem Action
50002 The system has detected an electrical compo-
nent failure.
Continue the procedure. If the problem persists, shut down the
system and restart it. If there is still a problem, report the System
Notice number to CryoCath Technical Support.
50003 The pressure is low in the system. Ensure the refrigerant tank is open.
50005
Focal Cathe-
a
ters
The safety system has detected fluid in the catheter and stopped the injection.
a
Keep both umbilicals connected and remove the catheter using
fluoroscopic guidance. Replace both the catheter and the
coaxial umbilical. If this message appears during an application
of RF energy, disconnect the cryoablation catheter from the
console before applying RF energy.
50005
Balloon
Catheters
The safety system has detected fluid in the catheter and stopped the injection.
a
a
Keep both umbilicals connected and remove the catheter using
fluoroscopic guidance. If resistance is felt during catheter
retraction, use the Manual Retraction Kit. Replace both the
catheter and the coaxial umbilical. If this message appears
during an application of RF energy, disconnect the cryoablation
catheter from the console before applying RF energy.
50006
Focal Catheters
50006
Balloon
Catheters
The safety system has detected blood on the
catheter handle, stopped the injection and disabled the vacuum.
The safety system has detected blood on the
catheter handle, stopped the injection and disabled the vacuum.
Disconnect the coaxial umbilical cable and remove the catheter
using fluoroscopic guidance. Replace both the catheter and the
coaxial umbilical cable.
Disconnect the coaxial umbilical cable and remove the catheter
using fluoroscopic guidance. If resistance is felt during catheter
retraction, use the Manual Retraction Kit. Replace both the
catheter and the coaxial umbilical cable.
50007 The safety system has detected fluid in the
console. The system is inoperable.
Remove the catheter using fluoroscopic guidance. Do NOT
power on again. Report the System Notice number to Technical
Support.
50008 The system has detected a software error and
stopped the injection.
Continue the procedure. If the problem persists, shut down the
system and restart it. If there is still a problem, report the System
Notice number to CryoCath Technical Support.
50009 The system has detected a failure. Reset the system by disconnecting the electrical umbilical
cable and reconnecting it. If the problem persists, report the
System Notice number to CryoCath Technical Support.
50010 The system has detected an electrical compo-
nent failure.
Reset the system by disconnecting the electrical umbilical
cable and reconnecting it. If the problem persists, report the
System Notice number to CryoCath Technical Support.
50011 The refrigerant delivery path is obstructed. Try again. Disconnect and reconnect the coaxial umbilical
cable. If the problem persists, replace the coaxial umbilical. Try
again before replacing the catheter. If the problem persists,
report the System Notice number to CryoCath Technical Sup-
port.
50012 The refrigerant delivery path is obstructed. Try again. Disconnect and reconnect the coaxial umbilical
cable. Try again before replacing the catheter. If the problem
persists, report the System Notice number to CryoCath Tech-
nical Support.
50013 The refrigerant level is too low to continue. Replace the refrigerant tank.
50014 The balloon is not sufficiently inflated. Ensure the tank is open and repeat inflation. Try again. If the
problem persists, replace the catheter.
50016 The injection has stopped because the Cryo-
Mapping temperature exceeded the preset value
Continue the procedure and try to reposition the catheter to
improve tip-tissue contact.
by more than 15 degrees.
50017 The operational temperature of the system is high
preventing proper operation.
Check whether the rear fans are working. Shut down the system
and wait 15 min before restarting. If the problem persists, report
the System Notice number to CryoCath Technical Support.
50018 The system is not ready. Wait 15 min before continuing the procedure. If the problem
persists, report the System Notice number to CryoCath Tech-
nical Support.
50021 Insufficient scavenging detected. Ensure nothing is obstructing the scavenging. If the problem
persists, report the System Notice number to CryoCath Tech-
nical Support.
50022 Mechanical component error. Continue the procedure. If the problem persists, shut down the
system and restart it. If there is still a problem, report the System
Notice number to CryoCath Technical Support.
50024 There is a problem with the refrigerant port. Disconnect the coaxial umbilical cable from the console and
make sure that the port, the catheter and the coaxial umbilical
are clear of obstructions and reconnect them. If the problem
54
System
Notice
Number Problem Action
persists, report the System Notice number to CryoCath Tech-
nical Support.
50025
50026
There is a problem with the injection process. Continue the procedure. If the problem persists, report the Sys-
tem Notice number to CryoCath Technical Support.
50027
50028
50031
50029 The safety system has detected a high level of
refrigerant flow and stopped the injection.
Try again. Disconnect and reconnect the coaxial umbilical
cable. If the problem persists, replace the coaxial umbilical. If
the problem still persists, report the System Notice number to
CryoCath Technical Support.
50030
Balloon
Catheters
50030
Focal Catheters
The safety system has detected a high level of
refrigerant flow and stopped the injection.
The safety system has detected a high level of
refrigerant flow and stopped the injection.
Try again. Disconnect and reconnect the coaxial umbilical
cable. Try again before replacing the catheter. If the problem
persists, contact CryoCath Technical Support.
Ensure the catheter is in good contact with the tissue. Try again.
Disconnect and reconnect the coaxial umbilical cable. Try
again before replacing the catheter. If the problem persists,
contact CryoCath Technical Support.
50032
Balloon
The safety system has detected a compromised
outer vacuum.
Replace the catheter.
Catheters
50033
50034
The system has an electrical component failure. Continue the procedure. If the problem persists, shut down the
system and restart it. If there is still a problem, report the System
Notice number to CryoCath Technical Support.
50035
The balloon is deflated. Repeat inflation. If the problem persists, replace the catheter.
Balloon
Catheters
60000 The coaxial umbilical cable is not connected
properly.
60001 The electrical umbilical cable is not connected
properly.
60002 The vacuum is disabled due to a problem with the
coaxial umbilical cable.
Disconnect both ends of the coaxial umbilical cable and reconnect them.
Disconnect both ends of the electrical umbilical cable and
reconnect them.
Disconnect both ends of the coaxial umbilical cable and reconnect them.
60003 Low refrigerant level. You can continue the current procedure but you must replace
the tank before the next case.
60004 Problem with scavenging. Ensure that the hospital scavenging system is turned on and
that the scavenging hose is securely attached.
a
Notice 50005 - Proximity to a running RF generator may trigger this notice. Turn off any RF generator in the vicinity before proceeding with the other
actions indicated.
Troubleshoot the touch screen
If the touch screen remains black but the console appears to be powered on, verify that the power switch on the back of the touch
screen is turned on. If necessary, turn the switch off and on to reset the touch screen.
55
Figure 46.
1 Touch screen power switch
Troubleshoot refrigerant flow
If you experience refrigerant flow system notices, consider these diagnostic questions:
• Has the tank been properly installed and connected?
• Has the console’s power been on for at least 15 min prior to the first injection?
• Has the tank valve been open for at least 15 min?
• Have you viewed the tank weight on the Service System screen?
• Is there sufficient refrigerant in the tank?
Important: If the tank has been stored below 15°C (60°F), it may take longer for the system to warm up.
Troubleshoot faulty date readings
If the console calendar has reset to an old date, or if incorrect dates are appearing on the patient list, contact CryoCath Technical
Support.
Technical specifications
Environmental parameters
Recommended transit temperature and humidity
Recommended storage temperature 15°C to 30°C (59°F to 86°F)
Operation temperature and humidity limitations 15°C to 30°C (59°F to 86°F) at altitudes less than 2400 m (8000 ft) above sea
Console specifications
The console is type CF (defibrillation proof), 100-120/230 V, 50/60 Hz, 10/5 A, with respect to electric shock, fire, mechanical
hazards only in accordance with IEC/UL 60601-1.
Warning: To avoid risk of electric shock, this equipment must only be connected to a supply main with protective earth.
The system must be installed by a qualified/trained Medtronic representative. To schedule a system installation, please contact your
Medtronic representative or Technical Support.
Caution: Use only isolated equipment (IEC 60601-1 Type CF equipment, or equivalent) with the console and catheters or patient
injury or death may occur. Do not allow leakage current from any connected devices to the patient to exceed 10 microamperes (µA)
under any circumstances.
Caution: The console meets the requirements of IEC60601-1. It is the user’s responsibility after installation to verify and ensure that
the console meets the applicable local electrical safety requirements.
Caution: Do not modify this equipment. Modifications may reduce system effectiveness and impact patient health.
The recovery time of the CryoConsole in the event of a defibrillation is 0 s. Therefore, there is no loss of basic safety and essential
performances of the CryoConsole in such an event.
The equipotentiality (chassis ground) function is to provide a direct connection between electrical equipment and the potential
equalization busbar of the electrical installation. The equipotentiality (chassis ground) is not a protective earth conductor. The
equipotentiality (chassis ground) can be used to perform the Electrical Safety Test and must be used to share a common ground with
the CryoConsole during normal operation. The equipotentiality (chassis ground) is directly connected to the CryoConsole chassis
−35°C to 58°C (−31°F to 136°F); 85% relative humidity (non-condensing)
level at humidity of between 30 and 75%.
56
and mains ground. The ground wire shall be between 96 in (244 cm) and up to 116 in (295 cm) with a minimum gauge of 10 AWG.
One end should have a terminal ring to facilitate connection to the equipotential pin located at the back of the CryoConsole and the
other end should have an alligator clip (or equivalent) to facilitate connection to available common grounds in the room.
Physical characteristics
Height (maximum) 1570 mm (62 in)
Height (minimum) 1260 mm (50 in)
Depth (maximum) 702 mm (28 in)
Depth (minimum) 579 mm (23 in)
Width (maximum) 690 mm (27 in)
Width (minimum) 550 mm (22 in)
Weight (without tank) 130.0 kg (286.6 lb)
Fuse Rating 10 A delay fuse; Length: 31.75 mm (1.25 in), Width: 6.35 mm (0.25 in), Tube:
Power cord type Hospital grade cord set for North America, Female: IEC 320, Male: Nema
ceramic, Endcaps: Nickel-plated brass
5-15IP, Clear, Cable 16 AWG (3) conductors, gray, UL listed, pattern shall
match retainer clip of CryoConsole
How supplied
The console is supplied in a customized crate.
Disposal regulations
End-of-service instructions and information are available for Medtronic products that are within the scope of the European Union
Waste Electrical and Electronic Equipment Directive (WEEE) 2002/96/EC.
Requirements for waste collection, reuse, recycling and recovery programs vary by regulatory authority at your location. Contact
your sales representative for complete end-of-service information on applicable products.
Caution: Discard all used catheters and sterile components in accordance with hospital procedures.
Console Component Information
This appendix contains detailed information about individual components for use with the console.
For information about interaction among the components and the console, see “The console, its components, and the catheters”,
page 9.
Warnings
These devices are components of the console. See “Warnings”, page 8 for important information related to the console.
Precautions
These devices are components of the console. See “Precautions”, page 8 for important information related to the console.
Technical specifications
These devices are components of the console. See “Technical specifications”, page 56 for information about environmental and
operating requirements for the console (except see the appropriate Medtronic balloon catheter technical manual for specifications
for the manual retraction kit).
Manual Retraction Kit
Intended Use
The sterile 20MRK Manual Retraction Kit is designed for use with compatible Medtronic cryoablation balloon catheters.
Description
The manual retraction kit provides an alternative means of inflating and deflating the balloon catheter, in the unlikely case that the
normal methods of inflating and deflating the balloon cannot be used. The manual retraction kit is a sterile part intended for single
use.
57
Figure 47. Manual Retraction Kit
1 Coaxial connector
2 Stopcock
3 Syringe
4 Stopcock handle
6 Syringe connector
7 Coaxial connector inlet
8 Vent
9 Locking pin
5 Closed position indicator
The manual retraction kit has three main parts:
• Coaxial connector – connects the manual retraction kit to the coaxial connector of the catheter handle.
• Stopcock – a three-position valve that allows and restricts flow. The closed position indicator on the stopcock handle points to
the closed passage for each stopcock position. (The stopcock is shipped preattached to the coaxial connector.)
• Syringe – creates vacuum to aspirate the catheter; injects saline solution into the balloon during inflation; extracts saline to
collapse balloon.
Instructions for Use
Notes:
• Two people are required for this procedure.
• Do not disconnect the coaxial and electrical umbilical cables until indicated in these steps.
Prepare the equipment
1. Unpack and assemble the manual retraction kit.
2. Verify that the stopcock and syringe are assembled as shown.
Release the vacuum and attach the coaxial connector
1. On the Therapy tab, touch Release Vacuum on the screen.
2. Disconnect the electrical umbilical cable and the coaxial umbilical cable from the catheter, as shown:
58
3. Push the syringe plunger in.
4. Connect the manual retraction kit coaxial connector to the catheter coaxial connector:
Apply vacuum to aspirate the catheter
1. Rotate the stopcock handle to close flow to the vent:
2. Pull the plunger out of the syringe to approximately 60 cm3.
3. Rotate the plunger to lock the syringe:
59
4. Rotate the stopcock handle to close flow to the catheter inlet:
5. Disconnect the syringe from the stopcock.
6. Rotate the plunger to unlock it.
7. Push in the syringe plunger to empty the syringe.
8. Reconnect the syringe to the stopcock.
9. Apply a second syringe stroke of vacuum to the catheter by repeating Step 1 through Step 8.
Prepare and perform saline inflation of the balloon
1. Ensure the flow to the catheter inlet is closed.
2. Disconnect the syringe from the stopcock:
60
3. Fill the syringe with 30-50 cm3 of saline.
Note: Minimum quantity is 20 cm3.
4. Connect the syringe to the stopcock:
5. Rotate the stopcock handle to close flow to the vent:
61
6. Inject the saline into the catheter (minimum 20 cm3):
Tension and deflate the balloon
1. Retract the saline, using two people, as follows:
a. Advance the blue tensioning button on the catheter handle.
b. At the same time, pull on the plunger to retract the saline.
2. Rotate the stopcock handle to close flow to the catheter inlet:
3. Consult the technical manual for the catheter for steps to remove the catheter from the patient.
Caution: Discard all used catheters and sterile components in accordance with hospital procedures.
62
Cleaning and Storage
Prior to use, store the manual retraction kit in accordance with temperature guidelines described in the technical manual for the
appropriate Medtronic balloon cryoablation catheter. You may wish to store the kit inside the console for easy access if needed.
The manual retraction kit is a sterile component intended for single use. Do not attempt to clean it.
Disposal
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See
http://recycling.medtronic.com for instructions on proper disposal of this product.
Caution: Discard all used catheters and sterile components in accordance with hospital procedures.
Physical characteristics
Length of assembled stopcock and syringe
(syringe plunger at bottom position)
Length of assembled stopcock and syringe
(syringe plunger extended to upper limit)
36 cm (14 in)
48 cm (19 in)
Auto Connection Box
Intended use
The 2037A Auto Connection Box is designed for use with any current model of the console.
Description
The auto connection box provides an electrical connection to the catheter. It is a required interface component for use in ablation
procedures and is connected to the following components:
• Console – The auto connection box has an electrical cable that attaches to the connector port on the front of the console.
• Electrical umbilical cable – The electrical umbilical cable connects the catheter handle to the CryoCatheter port on the auto
connection box.
• ECG cable (optional) – The ECG cable connects the hospital EP system (if used) to the Recording System port on the auto
connection box.
Instructions for Use
1. Power up the console and connect the auto connection box cable to the connector port on the front of the console at least
15 min before the first ablation procedure.
2. Connect the corresponding end of the electrical umbilical cable into the CryoCatheter port on the auto connection box.
3. Connect the corresponding end of the electrical umbilical cable into the catheter handle receptacle to provide electrical
connection.
4. If an ECG cable is to be used, connect it to the Recording System port on the auto connection box and into the hospital EP
recording system while the console main screen is displayed.
5. Perform ablation preparation and procedures as described in console and catheter documentation.
6. After the procedure is complete, remove the electrical umbilical cable from the catheter handle.
7. Disconnect the electrical umbilical cable from the auto connection box.
8. Disconnect the ECG cable, if it was used.
9. Disconnect the auto connection box from the console.
Cleaning and Storage
Wipe off the auto connection box with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Dry thoroughly.
Do not immerse in water.
Store the auto connection box inside the console while not in use.
Disposal
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See
http://recycling.medtronic.com for instructions on proper disposal of this product.
63
Physical characteristics
Cable length 122 cm (48 in)
Box dimensions Length: 14 cm (5.5 in)
Width: 7 cm (2.8 in)
Height: 5 cm (2.0 in)
Coaxial Umbilical Cable
Intended Use
The 203CX Coaxial Umbilical Cable is designed for use with any current model of the console. It is a sterile component intended for
single use.
Description
The coaxial umbilical cable transports liquid refrigerant to the catheter and returns waste refrigerant to the console for disposal. The
coaxial umbilical cable is required for the ablation procedure.
The coaxial umbilical cable is designed for use with compatible Medtronic cryoablation catheters.
The coaxial umbilical cable connects to:
• The catheter – One end of the coaxial umbilical cable connects to the catheter handle.
• The console – The other end of the coaxial umbilical cable connects to the front of the console at the coaxial connector port.
Instructions for Use
1. Unpack the coaxial umbilical cable.
2. Connect the coaxial umbilical cable to the catheter handle.
3. Connect the coaxial umbilical cable to the port located on the front of the console.
4. After the procedure is complete, disconnect the coaxial umbilical cable from the catheter handle and from the console.
Cleaning and Storage
Prior to use, store the coaxial umbilical cable in accordance with temperature guidelines described in “Technical specifications”,
page 56.
The coaxial umbilical cable is a sterile component intended for single use. Do not attempt to clean it.
Disposal
Do not dispose of this product in the unsorted municipal waste stream.
Caution: Discard all used catheters and sterile components in accordance with hospital procedures.
Physical characteristics
Length
183 cm (72 in)
Electrical Umbilical Cable
Intended Use
The 2035U Electrical Umbilical Cable is designed for use with any current model of the console. It is a sterile component intended
for single use.
Description
The sterile electrical umbilical cable provides an electrical connection to the catheter. The electrical umbilical cable is required for
the ablation procedure.
The electrical umbilical cable is designed for use with compatible Medtronic cryoablation catheters.
64
The electrical umbilical cable connects to:
• The catheter – One end of the electrical umbilical cable connects to the catheter handle.
• The auto connection box – The other end of the electrical umbilical cable connects to the CryoCatheter port of the auto
connection box.
Instructions for Use
1. Unpack the electrical umbilical cable.
2. Connect the corresponding end of the electrical umbilical cable to the catheter handle receptacle to provide electrical
connection.
3. Connect the corresponding end of the electrical umbilical cable to the CryoCatheter port on the auto connection box.
4. After the procedure is complete, remove the electrical umbilical cable from the catheter handle and from the auto connection
box.
Cleaning and Storage
Prior to use, store the electrical umbilical cable in accordance with temperature guidelines described in “Technical specifications”,
page 56.
The electrical umbilical cable is a sterile component intended for single use. Do not attempt to clean it.
Disposal
Do not dispose of this product in the unsorted municipal waste stream.
Caution: Discard all used catheters and sterile components in accordance with hospital procedures.
Physical characteristics
Length
122 cm (48 in)
Electrocardiogram (ECG) Cable
Intended Use
The 2035W Electrocardiogram (ECG) Cable is designed for use with any current model of the console and with Medtronic focal
cryoablation catheters. Its use is optional.
Description
The ECG cable connects the console auto connection box to a hospital EP recording system. This feature is used with Medtronic
focal cryoablation catheters only.
The ECG cable connects to:
65
• The EP recording system – Four 2 mm shielded connectors connect to an EP recording system.
• The auto connection box – The single-tip end connects to the corresponding port of the auto connection box.
Instructions for Use
1. Connect the single-cable end of the ECG cable to the auto connection box.
2. Connect the 4 shielded-tip jacks to the EP recording system.
3. Remove the ECG cable by unplugging it from the auto connection box and from the EP recording system.
Cleaning and Storage
Wipe off the ECG cable with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Dry thoroughly. Do not
immerse in water.
Store the ECG cable inside the console while not in use. Store it in accordance with temperature guidelines described in “Technical
specifications”, page 56.
Disposal
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See
http://recycling.medtronic.com for instructions on proper disposal of this product.
Physical characteristics
Length
81 cm (31.9 in)
Foot Switch
Intended Use
The 104FS Foot Switch is designed for use with the console.
Description
The foot switch allows you to start and stop injection of refrigerant by using your foot to press a pedal connected to the console. Its
use is optional. If you do not use the foot switch, you will control injections on the console screen and on the front of the console.
The foot switch has the following parts:
• Connection cable – Permanently attached cable connects to the 7-pin port on the back of the console.
• Foot pedal – The pedal unit contains a foot actuator pad that is pressed to start or stop the flow of refrigerant.
Instructions for Use
1. Plug the foot switch connection cable into the 7-pin port on the back of the console.
2. Position the foot switch where a person cannot inadvertently step on or trip over it.
3. To start the flow of refrigerant, push down on the foot switch for 2.0 s.
4. To stop the flow of refrigerant, press down on the foot switch for at least 0.5 s.
5. Remove the foot switch by unplugging its cable from the console port.
Cleaning and Storage
Wipe off the foot switch with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Dry thoroughly. Do not
immerse in water.
Store the foot switch inside the console while not in use.
Disposal
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See
http://recycling.medtronic.com for instructions on proper disposal of this product.
66
Physical characteristics
Dimensions Length: 17 cm (6.7 in)
Width: 15 cm (5.9 in)
Cord Length: 3.7 m (9.8 ft)
Scavenging Hose
Intended Use
The 1035-series Scavenging Hoses are designed for use with any current model of the console.
Description
The scavenging hose transports waste refrigerant from the console into the hospital suction or evacuation system. The scavenging
hose is required for the ablation procedure.
The scavenging hose connects to:
• The console – This attaches to the specified connector on the back of the console. Tighten the connection until it is finger tight.
• The hospital evacuation system – This attaches to the hospital evacuation system, often a wall receptacle. You may need an
adapter (available from Medtronic) to fit the hose. Y-block adapters (available from Medtronic) allow for two hoses to connect
to the same wall receptacle.
Instructions for Use
1. Prior to powering up the console, connect the scavenging hose to the console and to the hospital evacuation system.
2. When console use is complete, disconnect the scavenging hose from the console and the wall receptacle.
Cleaning and Storage
Wipe off the scavenging hose with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Dry thoroughly. Do
not immerse in water.
Store the scavenging hose by winding it around the designated pegs on the back of the console while not in use.
Disposal
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See
http://recycling.medtronic.com for instructions on proper disposal of this product.
Physical characteristics
Model
Model 1035FW (white)
Model 1035F (yellow)
Model 1035EW (white)
Model 1035E (yellow)
Model 1035DW (white)
Model 1035D (yellow)
Model 1035CW (white)
Model 1035C (yellow)
Model 1035G WAGD (7.5 mm) (Purple)
Model 1035H WAGD (5.5 mm) (Purple)
Length (four lengths available)
12 m (40 ft)
9 m (30 ft)
7.5 m (25 ft)
6 m (20 ft)
12 m (40 ft)
Scavenging hose adapter and Y adapters
Intended Use
The 1036-series scavenging hose adapters and Y adapters are designed for use with any current model of the console or
compatible scavenging hose. Other adapters may be necessary, depending on facility requirements or local standards.
Description
The adapters connect to the outlet end of the scavenging hose (the end near the wall receptacle) or to the hospital suction or
evacuation system (at the wall receptacle).
The scavenging hose adapter connects the scavenging hose to the hospital suction or evacuation system, in the case when the
scavenging hose connector is not compatible with the hospital’s wall receptacle.
The Y adapter allows two hoses to connect to a single wall receptacle.
Note: Y adapters may not be allowed in some areas. Check local regulations before using Y adapters.
67
Instructions for Use
1. Prior to powering up the console, connect the adapter or Y adapter to the hospital evacuation system and to the scavenging
hose or hoses. Tighten all connections until finger tight.
2. When console use is complete, disconnect the adapter or Y adapter from the wall receptacle and the scavenging hose.
Cleaning and Storage
Wipe off the adapter with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Dry thoroughly. Do not
immerse in water.
Store the adapter inside the console while not in use.
Disposal
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See
http://recycling.medtronic.com for instructions on proper disposal of this product.
Refrigerant Tank
Intended Use
The 103N2 Refrigerant Tank is designed for use with any current model of the console.
Description
The refrigerant tank supplies liquified nitrous oxide (N2O) to the console. Tanks may be refilled by approved gas suppliers.
The Refrigerant Tank has the following parts:
• Tank – The body of the tank sits upright on the load cell inside of the console.
• Valve knob – The knob on top of the tank controls the opening and closing of the valve that releases refrigerant into the console.
• Fitting – The tank connection fits into a nut on the console supply tubing. The wrench that is supplied with the console is used
to tighten the nut around the fitting.
Instructions for Use
Note: Prior to the ablation procedure, check the refrigerant level in the tank and change the tank if needed. For instructions see
“Interpret the refrigerant tank gauge reading”, page 47.
1. Open the door on the left side of the console and locate the tank.
2. Turn the knob on the top of the tank counterclockwise to open the tank valve and allow refrigerant flow to the console.
3. Close the console door during use.
4. After the ablation procedure has ended, turn the knob on top of the tank clockwise to shut off refrigerant flow to the console.
Note: Do not open the tank valve when the tank is not connected to the console.
Cleaning and Storage
Wipe off the refrigerant tank with a damp cloth. If necessary, use a mild detergent solution. Dry thoroughly. Do not immerse in water.
Store the refrigerant tank in accordance with storage parameters described in “Technical specifications”, page 56. The tank that is
in use is typically stored inside the console and connected to the supply tubing, with the top valve turned to the off position to prevent
refrigerant flow to the console while not in use. Make sure the safety strap inside the console is in place around the tank for secure
transport. See also “Use and store the refrigerant”, page 49.
Disposal
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See
http://recycling.medtronic.com for instructions on proper disposal of this product. See also “Ship the refrigerant tank”, page 49.
68
Physical characteristics
Net refrigerant weight (full tank, excluding weight of tank) 4.5 kg (10 lb)
Gross tank weight (full tank, including weight of tank) 10.9 kg (24 lb)
Purity 99.5% when humidity level <50 ppm
Wrench
Intended Use
The 1036W Wrench is designed for use with the refrigerant tank of any current model of the console.
Description
A 1-1/8 in (28.6 mm) open-end wrench that enables you to loosen and tighten the nut securing the refrigerant tank to the supply
tubing when changing tanks.
Instructions for Use
1. If using the wrench to loosen the nut on the supply tubing, make sure that the tank valve is in the closed position.
2. Fit the nut on the end of the tubing over the fitting on the tank to reestablish the connection between the supply tubing and the
tank. Keep the supply tubing in a vertical position while installing the tank.
Cleaning and Storage
Wipe off the wrench with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Dry thoroughly.
Store the wrench inside the console while not in use.
Disposal
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See
http://recycling.medtronic.com for instructions on proper disposal of this product.
Physical characteristics
Width at open end
28.6 mm (1-1/8 in)
Power Cord
Intended Use
The 1038N Power Cord is designed for use with any current model of the console.
Description
The power cord supplies electricity to the console. It is required for operation of the console. Additional power cords may be used
to adapt to local standards.
The power cord connects to:
• The console – The cord plugs into the specified inlet on the back of the console.
• A wall outlet – The cord connects to a source of line power.
69
Instructions for Use
1. Prior to turning on the console, connect the power cord to the console and connect it to a wall outlet.
2. Press the retainer wire over the console connection to hold the power cord securely in position.
3. After you perform proper shutdown procedure (see “Shut down the system”, page 41), you may leave the power cord attached
to the console. Store it by winding it around the designated pegs on the outside of the console.
Cleaning and Storage
Wipe off the power cord with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Dry thoroughly. Do not
immerse in water.
Store the power cord wrapped around the designated pegs on the outside of the console while not in use.
Disposal
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See
http://recycling.medtronic.com for instructions on proper disposal of this product.
Physical characteristics
Length
2.5 m (8.2 ft)
70
Medtronic, Inc.
*M991429A001*
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
+1 763 514 4000
Medtronic CryoCath LP
9000 Autoroute Transcanadienne
Pointe-Claire, Quebec H9R 5Z8
Canada
+1 514 694 1212
Technical Support +1 877 464 2796
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
+31 45 566 8000
Canada
Medtronic of Canada Ltd
99 Hereford Street
Brampton, Ontario L6Y 0R3
Canada
+1 905 460 3800
Technical manuals
www.medtronic.com/manuals
© 2018 Medtronic
M991429A001 1A
2018-12-21
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