CryoConsole Nonsterile Accessories Technical Manual March 2020

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. Arctic Front, CryoConsole, Freezor, 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. Defibrillation-proof type CF applied part Consult instructions for use Foot switch Power cord Cable Auto connection box Scavenging hose Scavenging hose adapter Y adapter ECG cable Wrench 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 use if package is damaged Lot number Fragile: handle with care

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Keep dry 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 Date of manufacture Medical device Model number Manufactured in Importer For US audiences only Caution: Federal law (USA) restricts this device to sale by or on the order of a physician This product complies with international protection rating IP68 with regard to ingress of dust or other foreign objects and immersion in water, as defined in IEC 60529.

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Introduction The CryoConsole (console) system includes sterile and nonsterile accessories. This manual provides detailed information about the nonsterile accessory components. For information about the CryoConsole or the sterile accessories, see the console operator’s manual. The information in this section applies to all the nonsterile accessory models.

CE mark of conformity Table 1. Regulatory approval information for CryoConsole nonsterile accessories Model CE mark applicability 2037A, 2035W, 104FS, 103NE, 124NE, 1038E, 1038U, 1038Y, 1035E, 1035EW, 1035F, 1035FW, 1035G, 1036L, 1036M, 1036N, 1036W 1035C, 1035CW, 1035D, 1035DW, 1035H, 1035Y, 1036A, These models are marketed in non-EU countries. They are not 1036AY, 1036B, 1036BY, 1036C, 1036CY, 1036D, 1036DY, approved for sale in the European Union. 1036E, 1036J, 1036K, 1036R, 1036V, 1036Y, 1036Z, 1038B, 1038B2, 1038C, 1038K, 124SK

Console Component Information The following Medtronic nonsterile accessory components are available for use with the CryoConsole. • • • • • • • •

Auto connection box Electrocardiogram (ECG) cable Scavenging hose Scavenging hose adapter and Y adapters Refrigerant tank Wrench Power cord Foot switch

These devices are components of the console. See the console operator’s manual for information about environmental and operating requirements for the console system. For the following information, see the instructions for use for the compatible catheter being used, as applicable: • • • • •

Indications for use Contraindications Intended patient population Clinical benefit Adverse events

For system-level warnings and precautions, see the console operator’s manual. For device-specific warnings and precautions, see the section in this manual for the applicable accessory model. If a serious incident related to the device occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body. If you find information in this manual that is incorrect or illegible, contact your Medtronic representative or your local competent medical authority.

Auto connection box Description The model 2037A auto connection box provides an electrical connection to the compatible catheter. The auto connection box 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 CRYO CATHETER port on the auto connection box. • ECG cable – The ECG cable (if used) connects the hospital’s compatible EP system to the RECORDING SYSTEM port on the auto connection box. Note: Any electronic recording or stimulation equipment used with the Medtronic catheter must be compliant with the applicable standards (such as 60601-1) and approved for use with intracardiac diagnostic catheters.

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Figure 1. Auto connection box

1 Electrical cable 2 Electrical umbilical receptacle

3 ECG cable receptacle 4 Auto connection box

Intended use The auto connection box is designed for use with any current model of the console. Intended purpose and intended users The auto connection box provides an electrical connection between the compatible catheter and the CryoConsole via the electrical umbilical cable. When used with the Freezor family catheters, the auto connection box also provides a connection between the catheter, ECG cable, and the corresponding pin or junction box of the hospital’s compatible EP recording system. The intended user is a clinical assistant (EP laboratory technician, nurse, etc.). Adverse events The following potential adverse event is related to the use of the auto connection box. For additional adverse events associated with the use of the product in conjunction with the compatible catheter, see the catheter instructions for use. • Electric shock, possibly resulting in arrhythmia or death Instructions for use To use the auto connection box, complete the following steps: 1. At least 15 min before the first ablation procedure, power up the console and connect the auto connection box cable to the connector port on the front of the console. 2. Connect the corresponding end of the electrical umbilical cable into the CRYO CATHETER 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’s compatible EP recording system while the console main screen is displayed. 5. Perform the ablation preparation and procedure as described in the 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 To clean the auto connection box, perform the following steps: 1. Clean the auto connection box by wiping it with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Caution: Do not immerse the auto connection box. Do not allow any fluid or moisture into any connector. The auto connection box and attached devices may not function correctly if the connectors get wet. Caution: Do not clean the auto connection box with aggressive solvents or it may be damaged. 2. Dry thoroughly. 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.

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Specifications Table 2. Auto connection box specifications Description Auto connection box physical dimensions

Specification Length: 11.43 cm (4.5 in) Width: 8.26 cm (3.25 in) Height: 3.56 cm (1.4 in) Electrical cable length (auto connection box to connector end) 244 cm (8 ft) Connector 1 (cable) CryoConsole auto connection box plug Connector 2 (receptacle) CRYO CATHETER receptacle for the electrical umbilical cable Connector 3 (receptacle) RECORDING SYSTEM receptacle for the ECG cable

Electrocardiogram (ECG) cable Description The model 2035W ECG cable connects the console auto connection box to a hospital’s compatible EP recording system. This feature is used with Medtronic focal cryoablation catheters only. Any electronic recording or stimulation equipment used with the Medtronic catheter must be compliant with the applicable standards (such as 60601-1) and approved for use with intracardiac diagnostic catheters. Figure 2. ECG cable

1 Electrical cable 2 Shrouded pin connectors The ECG cable connects to: • The EP recording system – Four 2 mm shielded connectors connect to a compatible EP recording system. • The auto connection box – The single-tip end connects to the corresponding port of the auto connection box. Intended use The ECG cable is designed for use with any current model of the console and with Medtronic focal cryoablation catheters. Intended purpose and intended users The ECG cable connects the auto connection box to the hospital’s ECG monitor and the corresponding pin or junction box of the compatible EP recording system. This allows intracardiac monitoring and recording to occur through the catheter electrodes. This feature is only available with Freezor family catheters. The intended user is a clinical assistant (EP laboratory technician, nurse, etc.). Adverse events The following potential adverse event is related to the use of the ECG cable. For additional adverse events associated with the use of the product in conjunction with the compatible catheter, see the catheter instructions for use. • Electric shock, possibly resulting in arrhythmia or death Instructions for use To connect the ECG cable, complete the following steps: 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. To disconnect the ECG cable, unplug it from the auto connection box and from the EP recording system. Cleaning and storage To clean the ECG cable, perform the following steps: 1. Clean the ECG cable by wiping it with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. 7

Caution: Do not immerse the ECG cable. Do not allow any fluid or moisture into any connector. The ECG cable and attached devices may not function correctly if the connectors get wet. Caution: Do not clean the ECG cable with aggressive solvents or it may be damaged. 2. Dry thoroughly. Store the ECG cable inside the console while not in use. Store it in accordance with temperature guidelines described in the console operator’s manual. 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. Specifications Table 3. ECG cable specifications Description Length (pin-to-connector) Connector 1

Specification 89 cm (35 in) Male, 4-pin connector (auto connection box RECORDING SYSTEM receptacle) Male, 2.0 mm shrouded pin connectors x4 (connects to the hospital’s compatible EP recording system) Freezor family of catheters

Connector 2 Compatibility

Scavenging hose Description The model 1035-series scavenging hoses transport waste refrigerant from the console into the hospital’s suction or evacuation system. The scavenging hose is required for the ablation procedure. Figure 3. Scavenging hose

1 Connector 1 2 Connector 2

3 Hose

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 2 hoses to connect to the same wall receptacle. Intended use The scavenging hoses are designed for use with any current model of the console. Intended purpose and intended users The scavenging hose transports the returning refrigerant from the CryoConsole into the hospital’s scavenging system. The intended user is a hospital biomedical engineer. Adverse events For adverse events associated with the use of the scavenging hoses in conjunction with the compatible catheter, see the catheter instructions for use. Instructions for use To use the scavenging hose, complete the following steps: 1. Before powering up the console, connect the scavenging hose to the console and to the hospital evacuation system. 2. When you are done using the console, disconnect the scavenging hose from the console and the wall receptacle. Cleaning and storage To clean the scavenging hose, perform the following steps: 1. Clean the scavenging hose by wiping it with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol.

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Caution: Do not immerse the scavenging hose. Do not allow any fluid or moisture into any connector. The scavenging hose and attached devices may not function correctly if the connectors get wet. Caution: Do not clean the scavenging hose with aggressive solvents or it may be damaged. 2. Dry thoroughly. 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. Specifications Note: The 1035Y connector can be used with two scavenging hoses to connect to the hospital’s evacuation system, as needed. Model 1035C 1035CW 1035D 1035DW 1035E 1035EW 1035F 1035FW 1035G WAGD (7.5 mm) 1035H WAGD (5.5 mm)

Color Yellow White Yellow White Yellow White Yellow White Purple Purple

Length 6 m (20 ft) 6 m (20 ft) 7.5 m (25 ft) 7.5 m (25 ft) 9 m (30 ft) 9 m (30 ft) 12 m (40 ft) 12 m (40 ft) 12 m (40 ft) 12 m (40 ft)

Scavenging hose adapters and Y adapters Description The model 1036-series adapters connect to the outlet end of the scavenging hose (the end near the wall receptacle) or to the hospital’s suction or evacuation system (at the wall receptacle). The scavenging hose adapter connects the scavenging hose to the hospital’s suction or evacuation system in situations when the scavenging hose connector is not compatible with the hospital’s wall receptacle. The following adapter models are available: • • • • • • • • • • • •

1036A 1036D 1036E 1036J 1036K 1036L 1036M 1036N 1036V 1036R 1036Y 1036Z

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. The following Y adapter models are available: • • • • • •

1036AY 1036B 1036BY 1036C 1036CY 1036DY

Note: For information about which adapter model to select, please contact your local Medtronic representative. Intended use The 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.

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Intended purpose and intended users The adapter connects the scavenging hose to the hospital’s scavenging system. This is done in situations when the scavenging hose connector is not compatible with the hospital’s wall receptacle. The intended user is a hospital biomedical engineer. Adverse events For adverse events associated with the use of the adapters in conjunction with the compatible catheter, see the catheter instructions for use. Instructions for use To use the adapter, complete the following steps: 1. Prior to powering up the console, connect the adapter to the hospital’s evacuation system and to the scavenging hose or hoses. Tighten all connections until finger tight. 2. When console use is complete, disconnect the adapter from the wall receptacle and the scavenging hose. Cleaning and storage To clean the adapter, perform the following steps: 1. Clean the adapter by wiping it with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Caution: Do not immerse the adapter. Do not allow any fluid or moisture into any connector. The adapter and attached devices may not function correctly if the connectors get wet. Caution: Do not clean the adapter with aggressive solvents or it may be damaged. 2. Dry thoroughly. 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 Description The refrigerant tank supplies liquified nitrous oxide (N2O) to the console. Tanks may be refilled by approved gas suppliers. Figure 4. Refrigerant tank

1 Valve knob 2 Fitting

3 Tank

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. Intended use The models 103NE, 124NE, and 124SK refrigerant tanks are designed for use with any current model of the console. Intended purpose and intended users The nitrous oxide refrigerant tank supplies pressurized liquid nitrous oxide (N2O) to the CryoConsole. 10

The intended user is a hospital biomedical engineer. Warnings and precautions • • • •

Do not put the refrigerant tank close to a heat source. Do not open the refrigerant tank when the tank is uninstalled and when the console delivery hose is not connected to the valve. Minimize exposure to N2O to prevent short-term behavioral and long-term reproductive health effects. Release of N2O may cause frost to form on neighboring surfaces. To prevent skin burns, avoid the surfaces closest to the refrigerant tank.

Adverse events For adverse events associated with the use of the refrigerant tank in conjunction with the compatible catheter, see the catheter instructions for use. Instructions for use To use the refrigerant tank, complete the following steps: Note: Before the ablation procedure, check the refrigerant level in the tank and change the tank if needed. 1. Open the door on the left side of the console and locate the tank. 2. Slowly 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. Caution: Do not open the tank valve when the tank is not connected to the console. 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’ for further instructions. 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 approximately 3.75 kg (8.3 lb) of refrigerant. Change the refrigerant tank The console holds 1 tank of refrigerant at a time. To change the tank, you need the following: • A full refrigerant tank supplied by Medtronic. • A 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. To 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.

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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. To 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.

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.

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To check for leakage: 1. Turn the knob on top of the tank counterclockwise to open the tank.

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. Cleaning and storage To clean the refrigerant tank, perform the following steps: 1. Clean the refrigerant tank by wiping it with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Caution: Do not immerse the refrigerant tank. Do not allow any fluid or moisture into any connector. The refrigerant tank and attached devices may not function correctly if the connectors get wet. Caution: Do not clean the refrigerant tank with aggressive solvents or it may be damaged. 2. Dry thoroughly. Store the refrigerant tank in accordance with the storage parameters described in the console operator’s manual. 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 the information about using and storing the refrigerant in the console operator’s manual.

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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 the refrigerant tank shipping information in the console operator’s manual. Specifications Model and type: Refrigerant tank weight, full: Nitrous Oxide (N2O) weight: Nitrous Oxide (N2O) purity:

103NE (supplied full), 124NE and 124SK (supplied empty) 11.4 - 11.8 kg (25 - 26 lb) 3.76 kg (8.3 lb) 99.5% when the humidity level is <50 ppm

Wrench Description The model 1036W wrench is a 28.6 mm (1 1/8 in) open-end wrench that allows you to loosen and tighten the nut securing the refrigerant tank to the supply tubing when changing tanks. Figure 5. Wrench

Intended use The wrench is designed for use with the refrigerant tank of any current model of the console. Intended purpose and intended users The wrench is used to loosen or tighten the nut that secures the refrigerant tank to the supply tubing. The intended user is a hospital biomedical engineer. Adverse events For potential adverse events, see the instructions for use for the compatible catheter being used. Instructions for use To use the wrench, complete the following steps: 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 To clean the wrench, perform the following steps: 1. Clean the wrench by wiping it with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Caution: Do not clean the wrench with aggressive solvents or it may be damaged. 2. 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.

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Specifications Table 4. Wrench specifications Description Width at open end Length

Specification 28.6 mm (1 1/8 in) with 60° and 15° angle head 28 cm (11 in)

Power cord Description The power cord supplies electricity to the console. The power cord is required to operate the console. Additional power cords may be used to adapt to local standards. Figure 6. Power cord

1 Console connector 2 Electrical power connector 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. Intended use Models 1038B, 1038B2, 1038C, 1038E, 1038K, 1038U, 1038Y, and other Medtronic qualified power cords, are designed for use with any current model of the console. Different power cords are available for use in Continental Europe and the United Kingdom. Intended purpose and intended users The power cord is used to connect the CryoConsole to the electrical system and supplies electricity to the CryoConsole. It is available in multiple configurations to meet local electrical requirements. The intended user is a hospital biomedical engineer. Adverse events The following potential adverse event is related to the use of the power cords. For additional adverse events associated with the use of the product in conjunction with the compatible catheter, see the catheter instructions for use. • Electric shock, possibly resulting in arrhythmia or death Instructions for use To use the power cord, complete the following steps: Note: Inspect the power cord before use. Do not use the power cord if it appears to be damaged. 1. Before turning on the console, connect the power cord to the console and connect it to a wall outlet. Warning: Avoid touching the stripped wires of the power cord when it is connected to the electrical source. 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 the console operator’s manual), 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 To clean the power cord, perform the following steps: 1. Clean the power cord by wiping it with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Caution: Do not immerse the power cord. Do not allow any fluid or moisture into any connector. The power cord and attached devices may not function correctly if the connectors get wet. Caution: Do not clean the power cord with aggressive solvents or the power cord may be damaged. 2. Dry thoroughly. 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.

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Specifications Length (all models)

2.5 m (8.2 ft)

Foot switch Description The model 104FS foot switch allows you to start and stop injection of the refrigerant for ablation with a focal catheter, or to inflate or deflate the cryoballoon, by using your foot to press a pedal connected to the console. Depending on the catheter type, the foot switch provides hands free control (start or stop) of the injection or mapping (Freezor family) or balloon inflation (Arctic Front family) functions. The foot switch also allows you to stop the current action being performed, similar to the Stop Current Action button on the front panel of the CryoConsole. 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. Figure 7. Foot switch

1 Connection cable 2 Foot pedal The foot switch has the following parts: • Connection cable – A 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. Intended use The foot switch is designed for use with the console. Note: Some older models of the console are not compatible with the foot switch. For any additional information, contact your local Medtronic representative. Intended purpose and intended users The foot switch is a foot-activated remote control that is used to enable and stop ablation mode. The intended user is a clinical assistant (EP laboratory technician, nurse, etc.). Adverse events The following potential adverse event is related to the use of the foot switch. For additional adverse events associated with the use of the product in conjunction with the compatible catheter, see the catheter instructions for use. • Electric shock, possibly resulting in arrhythmia or death Instructions for use To use the foot switch, complete the following steps: 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. Push down on the foot switch for 2.0 s to start the flow of refrigerant (focal catheter) or to inflate the balloon (cryoballoon). 4. Push down on the foot switch for at least 0.5 s to stop the flow of refrigerant (focal catheter) or to deflate the balloon (cryoballoon). 5. Remove the foot switch by unplugging its cable from the console port. Cleaning and storage To clean the foot switch, perform the following steps: 1. Clean the foot switch by wiping it with a damp cloth. If necessary, use a mild detergent solution or isopropyl alcohol. Caution: Do not immerse the foot switch. Do not allow any fluid or moisture into any connector. The foot switch and attached devices may not function correctly if the connectors get wet. Caution: Do not clean the foot switch with aggressive solvents or it may be damaged. 2. Dry thoroughly. 16

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. Specifications Table 5. Foot switch specifications Description Cable length Connector 1 Foot pedal dimensions Safety information

Specification 3.65 m (12 ft) 7-pin connector (connects to console lower rear connection panel) Length: 16.51 cm (6.5 in) Width: 19.05 cm (7.5 in) IEC 60601-1 IEC 60529, International Protection code IP68

Medtronic disclaimer of warranty For complete warranty information, see the warranty document for the console.

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© 2020 Medtronic M998619A001 A 2020-03-09

*M998619A001*

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