CryoConsole 106E2 and 106A2-K Operators Manual March 2020

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 CryoConsole

Scavenging hose Scavenging hose adapter Y adapter ECG cable Electrical umbilical cable Coaxial umbilical cable Wrench 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.

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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 Product documentation Package contents Reorder number Do not resterilize Do not reuse Do not freeze

Store above 0°C/32°F Do not use if package is damaged Lot number Serial number Fragile: handle with care This side up This way up Start Stop current action USB port Network port

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Keep dry Use by Sterilized using ethylene oxide Open Here (sterile device) 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 CE mark of conformity... 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... Position the console and lock its wheels... Open the refrigerant tank valve... Connect rear-attaching nonsterile components... Connect the EP connectivity or BNC cable (optional)... Power on the console... Connect front-attaching nonsterile components... Connect the sterile electrical umbilical cable... Connect the sterile coaxial umbilical cable... Check the refrigerant level... Other system connections and controls...

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Set up a patient record... Select from the main (Home) screen... Input the patient’s name... Input the patient or hospital ID number (optional)... Select the patient’s date of birth (optional)... Select the patient’s gender (optional)... Select the name of the physician performing the procedure (optional)...

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Perform cryotherapy... 25 Perform a cryoablation procedure with a balloon catheter... 25 Perform a cryoablation procedure with a focal catheter... 32 End a procedure... Add a diagnosis and outcome (optional)... Close the patient record... Shut down the system...

38 38 40 41

Review and download patient records... Review a patient record on the console screen... Download a patient record to USB flash drive... Privacy feature...

42 42 45 46

Maintenance... 47 Clean the console and components... 47 Preventive maintenance checks... 47 Troubleshooting... Work with System Notice messages... Download service files to USB flash drive... List of System Notice messages... Troubleshoot the touch screen... Troubleshoot refrigerant flow... Troubleshoot faulty date readings...

47 47 48 49 52 52 53

Technical specifications... Environmental parameters... Console specifications... How supplied... Disposal regulations...

53 53 53 53 53

Console Component Information... 54 Manual Retraction Kit... 54 6

Coaxial Umbilical Cable... 59 Electrical Umbilical Cable... 60

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Introduction to the CryoConsole CE mark of conformity Table 1. Regulatory approval information for CryoConsole Model

Notified body

106E2 106A2-K

106A2-K is only marketed in Australia and New Zealand, and is not approved for sale in the European Union.

Description and intended use The CryoConsole (the console), together with its components and specified catheters, is for use in performing cardiac ablation procedures. While in CryoMapping mode (with compatible Medtronic catheters that support this feature), the console causes alteration in cardiac conduction to allow the clinician to verify the ablation site and confirm that the catheter tip is positioned in the optimal location. 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 single-use device for purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of 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 sterile component prior to use. If the sterile packaging or sterile component is damaged, do not use the sterile component. Contact your Medtronic representative. • 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.

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• 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. • 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.

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 the manual retraction kit and the sterile cables, see Console Component Information, page 54. For information about the nonsterile accessory components, see the accessory documentation provided with the console. 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) - focal catheter is shown 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 Scavenging hose 4 Power cord

Figure 3. Console front control panel

1 Green Start button (indicated by ) 2 Stop Current Action button (indicated by

)

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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 connectivity connector 3 USB port

4 Network connector (inactive) 5 Speaker volume 6 BNC Injection Sync signal output

Figure 6. Lower-rear connection panel

1 Foot switch connector (optional) 2 Scavenging hose connector 3 Power cord inlet

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. Use the wrench to verify that the hose nut is tight. 3. Open the tank by turning the knob on the top of the tank counter-clockwise. 4. Close the console door.

Connect rear-attaching nonsterile components Figure 8. Lower connectors on back of console

1 Foot switch connector (optional) 2 Scavenging hose connector 3 Power cord inlet

4 Retainer clip 5 Equipotentiality (chassis ground)

Note: If using the foot switch, refer to the accessory documentation provided with the console. The use of the foot switch 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. 1. 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.) 14

2. 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. 3. 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 between the non-isolated Injection Sync BNC connector and 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 non-isolated 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 47. • If the touch screen remains black but the console appears to be powered on, refer to Troubleshoot the touch screen, page 52. When the console has finished the self-test, the Main screen appears, as shown:

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Figure 11. Main screen

Connect front-attaching nonsterile components Figure 12. Front-attaching nonsterile console components

1 ECG cable connection to the hospital EP recording system 2 Connection to the auto connection box

3 Connection to the console

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 13. The end of the cable snaps securely into the console connector and cannot be inadvertently pulled off.

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Figure 13. Auto connection box cable connector

1 Auto connection box cable connector

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Connect the sterile electrical umbilical cable Figure 14. Electrical umbilical cable connection

1 Catheter connection to the electrical umbilical cable 2 Electrical umbilical cable connection to the connection box 3 Electrical umbilical cable connection to the catheter 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 15. Coaxial umbilical cable connection

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 16.

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Figure 16. Coaxial connector

1 Coaxial connector (unplug cap before connecting) 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.

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 the accessory documentation provided with the console. 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 System Setup screen appears:

3. Check the Tank Level gauge. The amount of refrigerant consumed depends on the catheter and type of procedure used. If the tank needs to be replaced, see the accessory documentation provided with the console.

Other system connections and controls Other (optional) system connections exist on the console back connection panel:

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