Cardioblate CryoFlex Operators Manual Rev 1B

2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Cardioblate® and CryoFlex® are trademarks of Medtronic, Inc. Cardioblate® et CryoFlex® sont des marques commerciales de Medtronic, Inc. Cardioblate® und CryoFlex® sind Marken von Medtronic, Inc. Cardioblate® y CryoFlex® son marcas comerciales de Medtronic, Inc. Cardioblate® en CryoFlex® zijn handelsmerken van Medtronic, Inc. Cardioblate® e CryoFlex® sono marchi di fabbrica della Medtronic, Inc. Cardioblate® og CryoFlex® er varemerker for Medtronic, Inc. Cardioblate® ja CryoFlex® ovat Medtronic, Inc:n tavaramerkkejä. Cardioblate® och CryoFlex® är varumärken som tillhör Medtronic, Inc. Οι ονομασίες Cardioblate® και CryoFlex® είναι εμπορικά σήματα της Medtronic, Inc. Cardioblate® og CryoFlex® er registrerede varemærker tilhørende Medtronic, Inc. Cardioblate® i CryoFlex® są znakami towarowymi firmy Medtronic, Inc. Cardioblate® e CryoFlex® são marcas comerciais da Medtronic, Inc. Cardioblate® ve CryoFlex® Medtronic, Inc. şirketinin ticari markalarıdır. Cardioblate® a CryoFlex® jsou ochranné známky společnosti Medtronic, Inc. A Cardioblate® és a CryoFlex® a Medtronic, Inc. védjegye. Cardioblate® a CryoFlex® sú ochranné známky spoločnosti Medtronic, Inc. Cardioblate® ja CryoFlex® on ettevõtte Medtronic, Inc. kaubamärgid. Cardioblate® и CryoFlex® са търговски марки на Medtronic, Inc. Cardioblate® i CryoFlex® zaštitni su znakovi tvrtke Medtronic, Inc. Cardioblate® un CryoFlex® ir Medtronic, Inc. reģistrētas preču zīmes. „Cardioblate®“ ir „CryoFlex®“ yra „Medtronic, Inc.“ prekių ženklai. Cardioblate® şi CryoFlex® sunt mărci comerciale ale Medtronic, Inc. Cardioblate® и CryoFlex® являются товарными знаками Medtronic, Inc. Cardioblate® i CryoFlex® su žigovi preduzeća Medtronic, Inc. Cardioblate® in CryoFlex® sta blagovni znamki družbe Medtronic, Inc.

2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Table of Contents

Table of Contents 1 Introduction... 2 Device Description... 2 Indications... 2 Contraindications... 2 Warnings... 2 Precautions... 3 Adverse Effects... 3 2 System Setup... 4 Console... 4 Control Panel... 5 Installation... 5 3 Pre-Op Setup... 7 4 Performing Cryoablation... 11 5 Post-Op Take Down... 13 6 Maintenance... 14 Replacing Fuses... 14 Refrigerant... 14 Refrigerant Usage... 14 Shipping the Refrigerant Tank... 15 Changing the Refrigerant Tank... 15 Cleaning the Cardioblate CryoFlex Surgical Ablation Console and Accessories... 17 Internal Maintenance... 18 7 Troubleshooting... 19 8 Technical Specifications... 20 Surgical Cryoablation System Specifications... 20 How Supplied... 20 Electromagnetic Emissions and Immunity Declarations... 20 9 Warranties... 22 Limited Warranty for the Cardioblate® CryoFlex® Surgical Ablation Console... 22 Disclaimer of Warranty for the Accessories... 22

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Chapter 1

Introduction

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Device Description The Cardioblate CryoFlex Surgical Ablation Console is a cryoablative surgical device that is used in the cryosurgical treatment of cardiac arrhythmias. The system utilizes an argon-based cryogen for fast, controlled freezing. The system consists of the Cardioblate CryoFlex Surgical Ablation Console, connection components and accessories, and disposable cryoablation probes. Cryoablation During a cryoablation procedure, pressurized argon gas flows from the gas tank through the regulator, which maintains the gas flowing through the control panel at a constant pressure. The pressurized argon gas inside the control panel flows through a valve, which controls gas delivery to the cryoablation probe through the high-pressure connector on the front of the control panel. The console is equipped with a vent-valve that relieves the pressure for storage between uses. As the pressurized argon gas reaches the ablation segment of the probe, it passes through microholes that cause the pressure to drop dramatically. This pressure drop causes the temperature of the argon gas to decrease and results in freezing temperatures at the ablation segment of the probe.

Indications The Cardioblate CryoFlex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm, 10 cm, and 10-S probes plus the Cardioblate CryoFlex Clamp and Cardioblate CryoFlex Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Contraindications The Cardioblate CryoFlex Surgical Ablation Console, Clamps, and Probes are not designed for use inside a beating heart.

Warnings

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Refer to product literature included for each disposable device, including cryoablation probes and clamps, for further instructions and warnings specific to those devices.

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Cryoablation probes contain pressurized refrigerant during operation. Discontinue treatment immediately if a breach in the probe is suspected, as this may result in release of pressurized gas and injury to the patient or the user.

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Avoid contact between the cryoablation probe and the phrenic nerve to avoid injury.

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If an unanticipated event occurs, the injection of refrigerant can be stopped at any time by pushing the Stop Freeze button on the control panel.

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If you are unable to stop the injection, immediately turn the system off by using the power switch located on the side of the control panel or by disconnecting the power cord.

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Do not attempt to disconnect the probe or gas line during operation in the freeze mode as the sudden release of pressure may cause the probe or gas line to recoil, which may injure the operator. The system must be vented prior to disconnecting the probe and gas line.

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If the injection of refrigerant spontaneously stops before the preset time on the control panel has elapsed, replace the probe.

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To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

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The power cord may be used to disconnect the device from electrical power. Do not position the control panel so that it is difficult to remove the power cord.

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Do not modify this equipment.

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To avoid the risk of electric shock, do not touch the patient when installing or handling the Pressure Sensor Cable.

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Use caution when transporting the CryoFlex Console over rough or uneven surfaces with changes in height greater than 10 mm.

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Introduction

Precautions ■

Only appropriately trained personnel in a fully equipped facility should perform cardiac cryoablation procedures.

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Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

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This device is designed for use in an electromagnetic environment and may generate or be susceptible to electromagnetic interference. Refer to the electromagnetic compatibility section for the recommended environment for electromagnetic emissions and immunity.

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Ensure that equipment used with the system is electrically safe and does not expose the patient to hazards.

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Ensure that all pressure and regulator lines are securely connected.

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Always turn off the main gas cylinder valve prior to venting the inlet pressure line to ensure that excess pressure is safely vented.

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Perform a test injection before placing a probe on tissue to be ablated.

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Follow standard guidelines for the safe handling and storage of high-pressure gas cylinders.

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To prevent unwanted movement of the Surgical Ablation Console on an incline, position the locking casters on the low side of the incline.

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Do not disconnect the probe from the control panel until the procedure is finished, unless the probe needs to be replaced.

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Discard all used probes and clamps in accordance with hospital procedures.

Adverse Effects Potential adverse effects with this device are similar to other cardiac surgery procedures and may include the following: ■

bleeding

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reoperation

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extension of extracorporeal bypass

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heart rhythm disturbances (atrial and/or ventricular)

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pericardial effusion

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pericarditis

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cardiac tamponade

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pleural effusion

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mediastinitis

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conduction disturbances (SA/AV node)

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acute ischemic myocardial event

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thrombus formation

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low cardiac output

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stroke

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renal, gastrointestinal, or respiratory complications

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sepsis

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adjacent structural damage

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death

Cryoablation involving coronary vessels has been associated with subsequent clinically significant arterial stenosis. It is unknown whether cryoablation with the Cardioblate CryoFlex Surgical Ablation Probe will have such an effect, but as in all such procedures, care should be taken to minimize unnecessary contact with coronary vessels during cryoablation. Operator's Manual

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Chapter 2

System Setup

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Console 1 2 5 3

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1. 2. 3. 4. 5. 6. 7.

Pressure Sensor Cable Regulator Gas Hose Control Panel Argon Gas Tank (stored inside the tank carrier) Probe Connector Tank Carrier

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Figure 1. Surgical cryoablation probes and clamps are used to apply freezing temperatures to the heart. Refer to product literature included with cryoablation probes for further information. Products that are compatible with the Cardioblate CryoFlex Surgical Ablation Console include: ■

Cardioblate CryoFlex Surgical Ablation Probe, 7 cm

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Cardioblate CryoFlex Surgical Ablation Probe, 10 cm

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Cardioblate CryoFlex 10-S Surgical Ablation Probe, 10 cm

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Cardioblate CryoFlex Clamp and Surgical Ablation Probe, 10 cm

Note: The probes and clamps are Type CF applied parts and are designed for single patient use. The control panel can be locked to the tank carrier or used separately. A 3 m (10 ft) power cord is shipped separately. The tank carrier holds the tank and allows for safe transport and storage of the argon tank. It consists of two pieces: the front white section holds the control panel, and the back blue section holds the argon gas tank. The two pieces should be locked together during use and transport. The regulator attaches the gas tank to the control panel and regulates the pressure of argon gas supplied to the control panel. The 2.4 m (8 ft) gas hose (shipped separately) connects the gas tank and regulator to the control panel. The 2 m (6 ft) pressure sensor cable is shipped with the regulator.

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

System Setup

Control Panel 1 3 2 6 4 7 5

Figure 2. Control Panel 1. Display Screen: Shows freeze time duration, temperature of ablation segment, and user messages. 2. Freeze Timer Window: Use the black arrow keys to change the duration (in seconds) of the freeze. The timer on the Display Screen counts up from zero. 3. Target Temperature Window: Use the red and blue arrow keys to increase or decrease the target temperature. 4. Start Freeze Button: Press and hold for 2 seconds to start the injection of refrigerant into the probe. The green light above the button remains lit while refrigerant is flowing. 5. Message Indicator: Lights up when there is a message on the Display Screen for the user to read. 6. Stop Freeze Button: Press at any time to stop the injection of refrigerant. 7. Vent Button: Press to depressurize the gas line.

Installation Caution: Follow standard guidelines for the safe handling and storage of high-pressure gas cylinders. Caution: The Cardioblate CryoFlex Surgical Ablation Console meets the requirements of Underwriters Laboratories (UL). It is the user’s responsibility after installation to verify and ensure that the system meets the applicable electrical safety requirements with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1, CAN/CSA C22.2 No. 601.1-1, ANSI / AAMI ES60601-1, and CAN/CSA C22.2 No. 60601-1. Unpacking The system and its accessories are shipped in boxes and packed for protection. Upon receipt, open all the boxes to ensure that all equipment and accessories are included and that there is no evident shipping damage. Manage disposal in accordance with local statutory regulations. Gather the following items to assemble the Console: ■

Control Panel, shipped with the Operator's Manual

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Tank Carrier (blue and white sections)

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Power Cord appropriate for geography

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Gas Tank Regulator (supplied with wrench)

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Pressure Sensor Cable (provided with regulator or available separately)

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Argon Gas Tank (not supplied by Medtronic; obtain from hospital supplier)

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Gas Hose

Verify Voltage Setting This control panel is capable of running 120V or 230V AC power. Inspect the fuse block next to the power switch to verify that the setting is correct for your location. If the setting is not correct, refer to "Replacing Fuses" in Chapter 6 for instructions on how to change the voltage setting.

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Chapter 2

Figure 3. Fuse Block in 120VAC Configuration Selecting the Language for the Control Panel The control panel displays English by default. To change the displayed language, power off the control panel and set the DIP switches to the desired language as shown in Figure 5. 1. DIP Switches

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Figure 4. 1 2 3 4

1 2 3 4

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Figure 5.

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1. 2. 3. 4. 5. 6. 7. 8. 9.

English French Italian German Danish Spanish Swedish Portuguese Dutch

2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Pre-Op Setup

Pre-Op Setup

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Caution: Only appropriately trained personnel in a fully equipped facility should perform cardiac cryoablation procedures. Caution: Ensure that equipment used with the console is electrically safe and does not expose the patient to hazards. 1. Position the Surgical Ablation Console in the desired location. Push down the locks on the front wheels.

Figure 6. Front Wheels Caution: To prevent unwanted movement of the Surgical Ablation Console on an incline, position the locking casters on the low side of the incline. 2. Remove the control panel from the console by grasping the handles and lifting straight up until the control panel clears the hooks on the tank carrier, then tilt the control panel away from the tank carrier and toward the user. Set the control panel on a table. (The control panel must be removed from the tank carrier to access the back connections.) Note: The control panel can be operated while mounted on the tank carrier or without a tank carrier. 1. Handle

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Figure 7. Control Panel Handle 3. Connect the regulator to the gas tank by attaching the nut on the regulator (Figure 8, number 7) to the port on the tank. Use the wrench to tighten the nut. Note: The nut on the North American regulator turns counterclockwise to tighten. Caution: Ensure that all pressure and regulator lines are securely connected. 4. To connect the gas hose to the regulator, pull back on the outer collar of the gas hose to expose the inner collar. Place the inner collar over the gas hose stem (Figure 8, number 5) on the regulator and release the outer collar. The connector locks into place. 1 2 3 4

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1. 2. 3. 4. 5. 6. 7.

Regulator Pressure Sensor Cable Pressure Sensor Stem Gas Hose Gas Hose Stem Auxiliary Vent Valve Nut

Figure 8. Regulator and Connections 5. Connect the other end of the gas hose to the metal gas inlet port on the back of the control panel (Figure 9, number 2). (Both ends of the gas hose are the same.) Operator's Manual

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Chapter 3 6. The pressure sensor cable comes attached to the regulator. If it is not attached, line up the 4-pin connector to the pressure sensor stem (Figure 8, number 3) on the top of regulator and rotate the collar to tighten. 7. To connect the pressure sensor cable to the control panel, push the white plastic connector on the end of the pressure sensor cable onto the pressure transducer connection (Figure 9, number 3). It will click into place. 1. 2. 3. 4.

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Gas Hose Gas Inlet Port Pressure Transducer Connection Pressure Sensor Cable

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3 4

Figure 9. Control Panel Connections 8. Place the control panel back onto the tank carrier or position it on a table in the desired location. 9. Connect the power cable to the control panel, plug the power cord into an outlet, and turn on the power switch. Note: An optional user-provided equipotentialization conductor may be attached to the equipotentialization connector. The equipotentialization connector is used to connect the ground of the control panel to the ground of other instruments in a clinical setting. 1

1. Equipotentialization Connection 2. Power Switch 3. Power Cord

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Figure 10. Power Connections 10. Open the tank valve to begin the flow of gas and begin the self-test.

Figure 11. Note: Before opening the gas tank, verify that the auxiliary vent valve on the regulator is closed by turning the handle clockwise (Figure 8). If the auxiliary vent valve is not fully closed, gas will escape when the gas tank is opened. 11. Open the gas tank by turning the knob on the top of the tank counterclockwise. 12. The system performs a self-test then asks the user to attach the probe. Note: The system will not perform the self-test unless the gas tank is open. 8

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Pre-Op Setup

Figure 12. 13. To connect the probe to the control panel, orient the probe connector with the green arrow up (Figure 14) and the red stop sign down. 14. Push the probe connector into the control panel connector until the grips snap into place. Hold the connector as shown in Figure 13. Do not squeeze the grips.

Figure 13. Attach Probe Note: Do not use excessive force to connect the probe. If resistance is felt, manually vent the system as described in Chapter 6, Maintenance, and try connecting the probe again. Note: Do not press the top and bottom grips while inserting the probe connector into the control panel. Only one hand is required to make the connection. 15. Gently tug on the probe connector to ensure it is securely connected. 16. Pull out the single-use black pin on the left side of the probe connector and discard.

Figure 14. Remove Pin Operator's Manual

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Chapter 3 Caution: Do not pull the pin until the probe is securely connected. Caution: Do not disconnect the probe from the control panel until the procedure is finished, unless the probe needs to be replaced, as the probe will not function if reconnected. 17. Once the probe is attached, the control panel will display the time (defaults to zero), the temperature in Celsius (starts at ambient temperature), and an estimated number of minutes of cryoablation that the gas remaining in the tank will permit. Note: Change the tank if there is not enough gas to complete at least one full procedure. (See Changing the Refrigerant Tank in Chapter 6 for details.)

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Performing Cryoablation

Performing Cryoablation

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Caution: Always perform a test injection before placing the probe on tissue to be ablated. 1. Perform a test injection with the probe in the air. Press the Start Freeze button for at least 2 seconds to start the injection of refrigerant. 2. The green light above the Start Freeze button lights up to indicate that refrigerant is flowing.

Figure 15. Start Freeze Button 3. If performing a test injection with the probe alone, the temperature reading on the control panel should drop to −110°C within 20 seconds if the equipment is operating properly. At the end of the default time (60 seconds), the injection stops automatically and the temperature rises. Warning: If an unanticipated event occurs, the injection of refrigerant can be stopped at any time by pushing the Stop Freeze button on the console control panel. Warning: If you are unable to stop the injection, immediately turn the system off by using the power switch located on the side of the control panel or by disconnecting the power cord. Warning: Do not attempt to disconnect the probe or gas line during operation in the freeze mode. Always vent the system at the end of the procedure before removing the gas line. Note: If the probe needs to be replaced during a procedure, it is not necessary to vent the system. Refer to Step 6 in Chapter 5 for instructions on removing the probe. 4. Shape the probe and adjust the length of the freeze zone (if using the probe alone) by moving the white insulating sleeve up or down. 1. Ablation Segment 2. White Insulation Sleeve

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Figure 16. Surgical Ablation Probe For instructions on use of specific probes or clamp, refer to the Instructions for Use supplied with those devices. 5. Select the target time and target temperature for cryoablation. a. The default time for cyroablation is 1 minute. Press the black arrow keys to increase or decrease the ablation time. The default time can be adjusted before or during an injection.

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Chapter 4

Figure 17. b. The default temperature for cryoablation is set to full power (coldest possible temperature), which is displayed as a dashed line. The lowest targeted temperature that will display in the Target Temperature window is −95°C. Press the red and blue arrow keys to increase or decrease the targeted temperature.

Figure 18. 6. Position the ablation segment of the probe onto the tissue to be ablated, ensuring all adjacent tissue is protected to avoid inadvertent freezing. Warning: Refer to product literature included for each disposable device, including cryoablation probes and clamps, for further instructions and warnings specific to those devices. 7. Press and hold the Start Freeze button for 2 seconds to start cryoablation. Note: The timer on the control panel does not start until the temperature on the control panel drops below −40°C. Warning: Probes contain pressurized refrigerant during operation. Discontinue treatment immediately if a breach in the probe is suspected, as this may result in release of pressurized gas and possible injury to the patient. Warning: If the injection of refrigerant spontaneously stops before the default time on the control panel has elapsed, replace the probe. Warning: Do not attempt to disconnect the probe or gas line during operation in the freeze mode. Always vent the system at the end of the procedure before removing the gas line. 8. Freezing stops at the end of the preset time unless it is terminated earlier by pressing the Stop Freeze button.

Figure 19. Stop Freeze Button Warning: If an unanticipated event occurs, the injection of refrigerant can be stopped at any time by pushing the Stop Freeze button on the control panel. Warning: If you are unable to stop the injection, immediately turn the system off by using the power switch located on the side of the control panel or by disconnecting the power cord. 9. The system automatically vents after each injection. Venting is signaled by a loud hissing noise. 12

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Post-Op Take Down

Post-Op Take Down

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1. Close the gas tank by turning the knob on the top of the tank clockwise. Important: The tank must always be closed before venting the system to avoid venting all the gas in the tank. 2. Press the Vent button on the control panel. 3. The display screen will read “Close Gas Tank Valve and Press Vent Button.” Ensure that the gas tank is closed and press the Vent button again.

Figure 20. 4. The light above the button turns on to indicate that venting has been selected. The display screen will read “System Venting.” A loud hissing noise will be heard as the gas is vented from the gas line between the tank and the regulator. 5. The auxiliary vent valve on the regulator assembly can also be used to vent any remaining gas in the gas line. Open the auxiliary vent valve by turning the handle counterclockwise. Caution: Always turn off the main gas cylinder valve prior to venting the inlet pressure line to ensure that excess pressure is safely vented. 6. Disconnect the probe from the system.

Figure 21. a. With one hand, press the top and bottom grips of the probe connector at the same time. b. With the other hand, push the connector flange ring in slightly. c. Pull back to disconnect the probe from the control panel connector. d. Dispose of single-use accessories and probes according to hospital regulations. 7. Turn off the power at the switch on the side of the control panel. 8. Optional: Disconnect the gas hose from the regulator and control panel. 9. Optional: Disconnect the pressure sensor cable from the control panel. 10. Carefully store the reusable accessories.

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Chapter 6

Maintenance

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This section describes how to replace the fuses, change the refrigerant tank, and clean the outer surfaces of the console and its nonsterile accessories. Caution: Follow standard guidelines for the safe handling and storage of high-pressure gas cylinders.

Replacing Fuses The fuse block is part of the power switch. Use a standard screwdriver to pop out the fuse block insert. Replace blown fuses using the same amperage rating and physical geometry as the existing fuses. Reinstall the fuse block insert so that the arrow for the correct voltage lines up with the arrow on the housing. The voltage setting must match the supplied voltage for your location. Refer to Chapter 8 for correct fuse type. 1. Voltage Setting Arrows 2. Arrow on Housing

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2

Figure 22.

Refrigerant The grade 4.8 argon gas refrigerant can be obtained from local gas suppliers. It must be pressurized as follows and of a purity of at least 99.998%: Europe (50L tank) 31,000 kPa (4,500 psi or 310 bar)

USA (type BX, approximately 50L) 41,000 kPa (6,000 psi or 410 bar)

A tank of argon gas at these pressures can provide approximately 35 minutes (Europe) or 70 minutes (USA) of freeze time. The control panel sounds an alarm when 2 minutes of gas time remain. At least one spare tank of argon gas should be readily available for each procedure. When you receive the gas tanks, check that the labels on the tank identify the gas and the purity. If the labels are damaged or missing, call the gas supplier for a replacement. Always move gas tanks carefully. Be sure that the outlet valve is fully closed and the valve protection cap is properly secured. Always move gas tanks with carts or hand trucks designed for that purpose. Never drop the tanks or allow them to strike another tank. After moving a tank to its point of use, secure it using stands, clamps, or other securing devices recommended by the gas supplier.

Refrigerant Usage

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The console operates with a refrigerant tank that contains high-pressure argon gas. Store and handle the argon refrigerant tanks according to the hospital gas management policy.

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Do NOT use refrigerant tanks on anesthetic equipment.

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Do NOT open the valve on the argon tank until it is properly connected to the regulator and control panel.

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Maintenance

Shipping the Refrigerant Tank ■

Follow standard guidelines for the safe handling and storage of high-pressure gas cylinders.

Changing the Refrigerant Tank The tank carrier holds one tank of refrigerant at a time. To change the tank, you will need: ■

A full refrigerant tank (available from your hospital supplier)

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An open-ended wrench (supplied with the system)

Caution: Only use Argon gas tanks that meet the requirements of local regulations. In Canada, only use Argon gas tanks that meet CSA B51 requirements. Caution: Follow standard guidelines for the safe handling and storage of high-pressure gas cylinders. The blue section of the tank carrier can function as a dolly for loading and unloading the gas tank. 1. Close the tank by turning the knob on the top of the tank clockwise. 2. Press the Vent button on the control panel. The display screen will read “Close Gas Tank Valve and Press Vent Button.” 3. Ensure the gas tank is closed and press the Vent button on the control panel a second time. The light above the button lights up to indicate that venting has been selected. The following message appears on the display screen: “System Venting” 4. A loud hissing noise will be heard as the gas is vented from the gas line between the tank and the regulator. 5. The auxiliary vent valve on the regulator assembly can also be used to vent any remaining gas in the gas line. Open the auxiliary vent valve by turning the handle counterclockwise. Caution: Always turn off the main gas cylinder valve prior to venting the inlet pressure line to ensure that excess pressure is safely vented. 6. Use the power switch to turn off the control panel and disconnect the power cable. 7. Remove the control panel from the console by grasping the handles and lifting straight up until the control panel clears the hooks on the tank carrier, then tilt the control panel toward the user. Disconnect the pressure sensor cable and gas hose from the back of the control panel before moving it to a table. Warning: ALWAYS remove the control panel from the tank carrier before changing the tank to prevent user harm. If not, the tank carrier may fall forward when removing the tank. 8. Disconnect the regulator from the tank. a. Use the supplied wrench to loosen the nut. Note: The nut on the North American regulator turns clockwise to loosen. b. Unscrew the nut until the regulator assembly can be separated from the tank. c. Set the regulator assembly aside. d. Fit a cap onto the tank valve. 9. Push down the levers on the front wheels of the console to lock the wheels. 10. Unlock the supporting legs of the tank carrier. a. Pull on the knob at the back of the tank carrier and turn it 90 degrees to lock the knob open (Figure 23).

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Chapter 6

Figure 23. b. Pull the legs away from the tank carrier to extend them. c. Release and turn the knob so it snaps into the lower hole on the legs and locks the legs in the extended position (Figure 24).

Figure 24. 11. On the top of the tank carrier, a toggle clasp attaches to a post to lock the two pieces of the tank carrier together. Unlock the tank carrier by releasing the black toggle clasp then lifting the hook away from the post (Figure 25). Repeat on the other side.

Figure 25. Warning: The tank carrier dolly is heavy. Be ready to take its weight. Warning: Only use the tank carrier dolly for loading and unloading refrigerant gas tanks. Do not use the tank carrier to transport refrigerant gas tanks. 12. Separate the dolly from the tank carrier by lowering the dolly until all four wheels are on the ground. 16

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Maintenance

Figure 26. 13. Wheel the dolly away from the front section of the tank carrier. 14. Wheel the dolly to the location of the new refrigerant tank. 15. Stand the dolly up in a vertical position. (The back wheels will now be off the ground.) 16. Unbuckle the black straps holding the empty tank in the dolly. 17. Remove the empty tank from the dolly and set it aside. 18. Set the full tank into the dolly and buckle the straps. 19. Wheel the dolly back to the tank carrier and dock it with the front section. Line up the dolly so the black pegs on both sides of the dolly fit into the hooks on the front section (Figure 27). Lift the dolly into a vertical position. 1. Hooks 2. Peg

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2

Figure 27. 20. Lock the tank carrier together by placing the hooks on the top of the dolly over the posts on the front section. Press the black toggle clasps down to lock the two sections together (Figure 28).

Figure 28. 21. To fold and lock the supporting legs of the dolly, pull and turn the knob on the back of the dolly to retract the legs back into the tank carrier. Release the knob so it snaps back into the upper hole and locks the legs into place. 22. Connect the regulator assembly to the refrigerant tank. a. Remove the cap from the full argon tank. b. Connect the regulator assembly using the supplied wrench. c. Replace the control panel on the tank carrier.

Cleaning the Cardioblate CryoFlex Surgical Ablation Console and Accessories Ensure the console power is off and unplugged before continuing. Operator's Manual

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2012/OCT/10 at 9:12 a.m. Doc number: M950761A001 Rev. 1B [Multi26] Printspec full-b - 8.5 x 11 inches

Chapter 6 Use a mild solution of soap and water or other suitable nonabrasive hospital cleaning agent to wipe the exterior surfaces of the console and tank carrier. Use care when cleaning keypad and display screen. If the control panel is deteriorated or worn, contact Medtronic Customer Service immediately. Caution: Do not expose the console, accessories, or electrical connectors to harsh cleaning fluids or solvents.

Internal Maintenance The Cardioblate CryoFlex Surgical Ablation Console has no internal user serviceable parts or operator adjustments. Contact Medtronic Customer Service for service contract information.

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Operator's Manual

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