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CEDTG200
Instructions for Use
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Medtronic CEDTG200 Instructions for Use

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DiamondTemp™
RF Generator
User Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.
DiamondTemp™, Valleylab™

Contents

10.3 Connecting the cables and accessory components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
10.4 Advanced Settings screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
10.5 Configuration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
10.6 Contact Impedance screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
10.7 Ablation Treatment screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10.8 Indicators and informational messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
10.9 Operation sequence for the generator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
11 DiamondTemp ablation system architecture and cybersecurity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
12 Maintenance and service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
12.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
12.2 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
12.3 Replacing fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
13 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
14 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
15 Guidance and manufacturer’s declarations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
16 Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
16.1 Mains input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
16.2 Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
16.3 RF output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
16.4 Heating Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
16.5 Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
16.6 Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
16.7 Measurement accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
16.8 Mechanical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
16.9 Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
16.10 Output power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
17 Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
18 Glossary of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
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1 Device description

The Medtronic DiamondTemp FASTR RF generator (model CEDTG200) is part of the DiamondTemp ablation system, which also includes the DiamondTemp ablation catheter, DiamondTemp irrigation pump, DiamondTemp catheter-to-RF generator (RFG) cable, DiamondTemp GenConnect cable, DiamondTemp EGM cable, and DiamondTemp irrigation tubing set.
The DiamondTemp ablation system is designed to deliver radiofrequency (RF) energy to the cardiac anatomy via the DiamondTemp catheter. The DiamondTemp RF generator provides RF energy and temperature monitoring functions, as well as control and communication to the DiamondTemp irrigation pump and commercially available external devices, such as cardiac stimulators, electrophysiology (EP) recording systems, and EP navigational and mapping systems like the EnSite Precision™ or EnSite™ Velocity™ Cardiac Mapping System (Abbott, MN).
The generator operates in temperature control mode. The desired catheter tip-to-tissue temperature is selected by the user. Thermocouples in the catheter tip provide temperature feedback and the generator automatically adjusts the power output to maintain the desired tip-to-tissue temperature.
The generator (Figure 1) has a touch-screen display, control buttons, and a control knob for modifying and controlling ablation parameters during the procedure. Ablation parameters such as temperature, power, impedance, duration, and irrigation flow rate are displayed on the front panel and can be recorded and saved by the generator in a format that can be downloaded to a computer or a USB flash drive.
Audible indicators, visual indicators, and informational messages (with codes) are sounded out or displayed on the touch-screen panel of the generator. A foot switch is also included with the generator and may be used as an option to start or stop RF energy delivery.
The generator can be placed on a cart or a table top. The generator has a power ramp time programmed to reach temperature set-point in approximately 1 second. Note: There are many factors that influence the time to reach the temperature set-point: tissue contact, tissue morphology and
thickness, etc. The actual ramp time to reach maximum power may be greater than the programmed ramp time.

Figure 1. DiamondTemp RF Generator

1 Touch-screen display 2 Control knob

2 Indications for use

The DiamondTemp RF generator is designed for use with the DiamondTemp ablation system. Refer to the DiamondTemp catheter instructions for the indications for use. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with the DiamondTemp catheter before using the generator.

3 Principle of operation

The generator operates by delivering RF energy, via the catheter, to discrete regions of the cardiac anatomy. The application of RF energy causes localized thermal injury, which results in a conduction block at the targeted location.
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4 Contraindications

The contraindications listed in the DiamondTemp catheter instructions apply to the use of the DiamondTemp generator. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with the DiamondTemp catheter before using the generator.

5 Warnings and precautions

• Refer to the DiamondTemp catheter instructions for warnings and precautions related to the use of the DiamondTemp ablation system.
• The generator materials are not compatible with magnetic resonance imaging (MRI).
• The generator is designed for use only with the DiamondTemp catheter, catheter-to-RFG cable, irrigation pump, tubing set, and GenConnect cable. Use of other devices or improper cables may cause conditions in the operation of the generator that may result in hazards to the patient.
• There is a direct electrical connection to the catheter electrodes through the EGM connection cables or the generator. Improper use may be dangerous for the patient.
• Do not touch the accessible contacts of the connectors while touching the patient.
• To avoid unintentional skin burns to the patient at the return pad site during RF energy delivery, do the following: – Minimize the distance between the return pad and the operating field. – Minimize skin-to-skin contact between parts of the patient’s body by covering these areas with dry gauze. – When using multiple ablation devices, remove those devices not actively in use from patient contact. In all cases, monitoring
systems incorporating high frequency current-limiting devices are recommended.
– Ensure the entire area of the return pad makes reliable contact with the patient’s body during ablation. Using the RF START
button to initiate an ablation results in continuous activation of RF energy output for the programmed duration. Do not remove the return pad while the system is ablating.
• Radiofrequency temperature and power should not exceed the maximum limits specified in the catheter instructions.
• The Service Communication port and Remote Control port on the rear panel are for service only and no connections should be made during normal use.
• The USB port on the rear panel is used to export generator data stored in internal memory. This data contains ablation data from previous cases. Exporting of the data should only be performed when the system is not in use.
• Failure of the generator could result in an unintended increase of output power. Monitor informational messages displayed by the generator and the irrigation pump.
• It is the responsibility of hospital personnel to use compatible return pads as specified in Chapter 9 and Chapter 10 of this user manual. Improper return pad use may result in skin burns to the patient. When applying the return pad, position the lead such that contact with the patient or other leads is avoided.
• The generator should be placed on a hard, level surface and not stacked on other equipment.
• Do not modify the generator or accessory components. Modifications may reduce system effectiveness and impact patient health.
• The generator should not be used with a Booker box or equivalent devices.
• All devices connected to the generator must be safe for the patient per specifications in IEC 60601-1 and IEC 60601-2-2. Improper use may be dangerous for the patient.
• When using the generator with the DiamondTemp catheter, the generator can be operated only in temperature control mode.
• The patient should not come into contact with grounded metal parts or metal parts that have considerable ground capacity (for example, operating table).
• To avoid the risk of explosion, do not use the generator in the presence of flammable anesthetics or gases.
• To avoid the risk of electrical shock or fire, do not expose the generator to excessive moisture, especially when power is connected. Make sure that the connectors to the catheter and cables are completely dry before connecting.
• The rear panel of the generator should remain readily accessible, so the power cord may be easily detached from the mains power module, should that become necessary as part of providing mains isolation.
• Ensure that the return pad is positioned and connected properly. RF application will not start if the return pad is missing or incorrectly connected to the generator.
• Verify effective contact between the patient and the return pad whenever the patient is repositioned. Patient movement may disrupt return pad contact, resulting in patient injury or extended procedure times.
• Before increasing any ablation settings, such as temperature set-point or ablation duration, or before performing several consecutive ablations with short off-periods, recheck the adherence of the return pad and its connections.
• Loss of contact between the return pad and the patient results in an error message, as controlled by the impedance cut-off set-point (11, Figure 7).
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• Read and follow the manufacturer’s instructions for use with the return pad. Use only return pads that meet appropriate regulatory requirements.
• All reusable accessories should be visually inspected on a regular basis to avoid system malfunction and maintain patient safety. No broken insulation of wires is allowed.
• Once the generator output START button is pressed, it will remain energized until either the front panel RF STOP button is pressed or until the foot switch is released.
• Before use, inspect the generator and the packaging to verify that no damage has occurred. Do not use damaged products.
• Do not immerse the generator in any liquid or expose the generator to steam autoclave or ethylene oxide (EtO) sterilization.
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth ground.
• Electromagnetic interference (EMI) from the environment or produced by the generator may adversely affect the performance of other equipment, including that of EP recording, mapping, or navigation systems. Excessive EMI may cause the generator to enter a Safe State, which requires a reboot. The generator is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Note: The emission characteristics of this equipment make it suitable for use in industrial areas and hospitals. It is not intended for use in a residential environment where this equipment might not offer adequate protection to radiofrequency communication services. Use in such environments might require mitigation measures, such as relocating or reorienting the equipment.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the DiamondTemp system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• Position connecting cables to avoid contact with the patient and other electrical leads.
• If for any reason (including EM interference) the generator loses communication with the irrigation pump, or if the irrigation pump flow becomes 0 mL/min, the generator displays a message indicating that the condition should be corrected before any other steps are taken.
• During use of the RF generator, pay attention to all messages, error codes, warnings, indicators, and tones, and exercise caution as needed.
• Do not attempt ablation without the use of the irrigation pump. Before attempting ablation, make sure the pump flow rate is at the minimum continuous flow and the pump is actively communicating with the generator.
• If the DiamondTemp system is used in conjunction with a compatible mapping system and GenConnect box (or similar connection box), consult their respective instruction manuals to ensure correct connectivity and use. Construct the 3D anatomic map of the region of interest only after all mapping catheters, the DiamondTemp catheter, and all respective cables and neutral electrodes (including the ablation return pad) are completely and properly connected and positioned at the cardiac location of interest. The subsequent addition of catheters or electrodes may lead to inaccurate anatomic mapping and may require remapping.
• Do not stack more than two generator shipping boxes on top of each other.
• If a serious incident related to the device occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body.
• Carefully inspect the package before opening. If the package has been damaged or opened, do not use and contact your Medtronic representative.
• If you find information in this manual that is incorrect or illegible, contact your Medtronic representative.

6 Potential adverse events

The potential adverse events that may be associated with ablation procedures can vary greatly in frequency and severity and may necessitate additional medical intervention, including surgery. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with each DiamondTemp catheter before using the DiamondTemp generator.

7 How supplied

The DiamondTemp generator is supplied with the following accessories and documentation. The generator and accessories are packaged nonsterile and are not intended for sterilization.
• Foot switch
• Power cord
• User manual
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The following additional accessories may be used with the DiamondTemp ablation system. Read all applicable instructions before use.
• DiamondTemp catheter-to-RFG cable (supplied separately)
• DiamondTemp GenConnect cable (supplied separately)
• DiamondTemp EGM connecting cable, 4 male 2.0 mm shrouded connectors (supplied separately)
• Return pad - single-use, nonsterile, adult patient return pads that utilize high-moisture, conductive adhesive with 2.7 m (9 ft) cord, for example the Valleylab E7507, E7507DB, or equivalent (not supplied)
Note: The term "return pad" is used throughout this manual and on the RF generator user interface. A return pad is also commonly called dispersive electrode, dispersive indifferent patch (DIP), grounding pad, patient return electrode, or passive/plate electrode.
Note: Ensure that the connector on the return pad cable is compatible with the DiamondTemp RF generator port.
• Grounding cable, equipotential connector, DIN 42801, or equivalent (not supplied)
• Serial communication cable, shielded, DB-9 connector, EIA RS-232, or equivalent (not supplied)
• Video output cable, shielded, DB15 connector, VGA, or equivalent (not supplied)

8 Unpacking the generator

Carefully remove the generator from the shipping container. Unpack the user manual and all accessories to be used with the generator. Inspect all items for possible damage during shipment. If any items are damaged, do not use them and contact a Medtronic representative.

9 Setting up the generator

The generator is intended for use with the DiamondTemp catheter-to-RFG cable only (supplied separately). The catheter-to-RFG cable connects the generator to the catheter. The catheter-to-RFG cable plugs into the front of the generator. When using the DiamondTemp ablation system with a compatible mapping system, the GenConnect cable (supplied separately) can be connected between the catheter-to-RFG cable and the generator to the GenConnect box (or similar connection box) (Section 10.3). Consult the respective instructions for the catheter-to-RFG and GenConnect cables. Do not use cables with devices not indicated in the respective instruction manuals.
The generator is designed for use with a one return pad, which connects to the front of the generator. Apply the return pad per its instructions and according to the guidance in Section 9.2 of this user manual.
The generator is intended for use with the DiamondTemp irrigation pump and DiamondTemp irrigation tubing set only (supplied separately). Included with the irrigation pump is a standard Ethernet cable to connect the irrigation pump to the generator. (See the irrigation pump user manual for more information.)

9.1 Technical safety inspections

The following inspections for safety must be performed at first use and after each repair.
• Perform a general inspection of the generator: – Assure the front and rear panels are not loose. – The touch-screen display must not show signs of damage.
• Check that the selector knob is securely connected and able to easily rotate.
• Perform a visual and functional inspection of the accessories: – Check the power cord and connector for any damage. – Check the connecting cable input for the return pad electrode. – Check the foot switch and its connector to ensure that it is not damaged and that it functions correctly.
• Check that the catheter (supplied separately) is connected appropriately.
• Check the return pad connector on the front panel of the generator for proper connection.
• Check the power cord connector for damage.
• Before operation, ensure that all connections are established and checked.
• The rear panel of the generator should remain readily accessible so that the power cord may be easily detached from the mains power module. The means of isolating equipment from mains are provided by a power entry module with detachable power cord.

9.2 Handling the return pad

One (1) return pad is required in order to operate the generator. The generator does not deliver RF energy without a return pad properly connected. If the return pad is or becomes disconnected, the generator will either not allow entry into RF energy delivery mode or will terminate the delivery of RF energy with a ‘High Impedance’ informational code. The RF generator does not implement a continuity monitor or a contact quality monitor for the return pad. For optimal performance, the self-adhesive return pad should be applied close
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to the operating field. Figure 2 shows the recommended locations for the return pad. Ensure that the entire area of return pad is reliably attached to a suitably prepared and appropriate area of the patient’s body, as defined by the return pad manufacturer. Use only a compatible return pad (see Chapter 7).

Figure 2. Return Pad Positioning

10 Directions for use

Note: The screen images shown in this user manual are representative of what is seen on-screen with the software; actual images
may differ slightly.

10.1 Electrical connections

The generator operates using line power of 100 to 240 V~ 50/60 Hz. To avoid the risk of electric shock, connect only to a hospital-grade grounded power outlet. The means of isolating equipment from mains are provided by a power entry module with detachable power cord. The generator is not battery powered and cannot be moved during use.

10.2 Turning the generator on and off

Before operation, the generator must be placed on a stable surface with adequate circulation of air around the device to avoid overheating. Additionally, the generator must be protected from moisture, contamination, and contact with flammable or explosive substances.
Ensure that the power cord is plugged in to a power line of 100 to 240 V~ 50/60 Hz. Connect the power cord only to a hospital-grade grounded power outlet and to the rear AC power cord inlet, as depicted in Figure 3. The grounding cable serves the purpose of equipment potential equalization and should be connected to the equipotential (grounding) stud located on the rear panel of the generator. The other end of the grounding cable should be connected to the grounding stud of another medical electrical equipment. The daisy-chaining of grounding cables ensures that relevant medical electrical equipment operates at the same potential, thereby reducing the chances of electrostatic or AC potential build-up. The power switch is located on the back panel of the generator near the power cord inlet. Turn on the switch at the rear of the generator. Next, to start the generator, depress the soft power button on the lower-left front panel of the generator, as shown in Figure 4. This button appears green when the generator is on, and amber when the generator is in standby mode. An image with the Epix Therapeutics logo will appear on the touch-screen display on the front of the generator after this button is depressed. Once turned on, the generator will perform a self-test. Once the self-test has passed, an audible tone is heard, and the touch-screen display will show the Advanced Settings screen in standby mode with the word “STANDBY” displayed in the top center of the screen.
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The generator has four screen options that will be used during the procedure:
• Advanced Settings screen
• Contact Impedance screen
• Ablation Treatment screen
• Configuration screen
Unless otherwise instructed by an on-screen message, the device should be powered down by first pressing the soft power on/off button on the front panel (1, Figure 4), not the rear power switch. Once the device returns to standby mode (front panel button illuminated amber in color), the device may be completely powered off by switching the rear panel power switch (8, Figure 3) to the 0 position.

Figure 3. RF Generator Rear Panel

1 EP mapping system connection for EGM output and pacing 2 Video Output port 3 Serial Output port 4 USB port 5 Foot switch plug

Figure 4. RF Generator Front Panel

6 Equipotential (grounding) stud 7 AC power cord inlet 8 Power switch 9 Pump control port (using Ethernet cable)
1 Soft power on/standby button 2 Touch-screen display 3 Power indicator – green when power is on 4 Fault indicator – red when a fault condition is encountered
5 Catheter-to-RFG cable port 6 Return pad connection port 7 RF STOP - generator stop button 8 RF START - generator start button
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10.3 Connecting the cables and accessory components

Use only the cables, accessories, and catheters provided or recommended. Refer to Chapter 7 for a list of supplied components and compatible devices.
The irrigation pump and the generator must be used in communication mode. To establish this mode, plug the Ethernet cable provided with the irrigation pump into the port on the rear panel of the pump, and connect the other end to the Pump Control port on the rear panel of the generator (9, Figure 3). Once communication is established between the two devices, a communication icon (5, Figure 7) will be displayed on the upper portion of the generator touch screen.
Note: When communication is established between the two devices, modifications to the flow rate or flow rate set-points on the generator or pump will be enacted. However, the generator should be used to control the irrigation pump during the procedure.
Once the return pad has been adhered to the patient (Section 9.2), the return pad connector may be plugged into the front panel of the generator (6, Figure 4).
Plug the sterile catheter-to-RFG cable into the catheter interface cable port on the front panel of the generator, marked by the catheter icon (5, Figure 4). The multi-pin connector of the catheter-to-RFG cable, which has a green band on the connector to match the green connector on the generator, will lock into place once plugged into the generator. In order to disconnect the catheter-to-RFG cable plug, its corrugated sleeve must be slid back. When ready to connect the catheter, plug the distal end of the sterile catheter-to-RFG cable into the back connector of the catheter. Refer to the catheter-to-RFG cable instructions for more detailed information.
Signals from the electrodes located on the tip of the catheter are passed through the generator and can be accessed for intracardiac electrogram recording, stimulation, and location guidance purposes from the output port labeled with the ECG/Pace symbol on the rear panel of the generator (1, Figure 3). An EGM cable can be plugged into the output port to route these signals to the appropriate recording and mapping system. The signals on the output port are filtered; however, electromagnetic interference from the environment or from the generator may affect recording and mapping systems. Connectivity to such systems should be made with caution, avoiding unnecessary cable loops. Also, it is recommended to use monitoring systems that incorporate high frequency current-limiting devices.
The DiamondTemp system can also be used with a compatible cardiac mapping system (such as the Abbott EnSite™ system). When connecting the DiamondTemp system to the mapping system, use a GenConnect box (or similar connection box). For this purpose, use the GenConnect cable. Connect one end of the GenConnect cable to the catheter-to-RFG cable. Connect the distal end of the GenConnect cable to the generator. Connect the grey 9-pin connector to the catheter input of the GenConnect box. Connect the black 14-pin connector to the RF generator output of the GenConnect box. Figure 5 and Figure 6 provide connectivity diagrams for using the DiamondTemp catheter and DiamondTemp RF generator, without the mapping system and with the mapping system. Confirm the correct connectivity by using the 3-D navigation function of the mapping system. Use the mapping system and the GenConnect box according to their respective instructions. Connect the return pad directly to the generator.

Figure 5. Connectivity Diagram between Catheter and RF Generator

1 DiamondTemp RF generator 2 26-pin male connector to RF generator 3 DiamondTemp cath-to-RFG cable
4 19-pin male connector to DiamondTemp ablation catheter 5 DiamondTemp ablation catheter
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Figure 6. Connectivity Diagram between Catheter and RF Generator When Using a Mapping and Navigation System

1 DiamondTemp ablation catheter 2 DiamondTemp cath-to-RFG cable 3 9-pin quick connector 4 DiamondTemp GenConnect cable 5 DiamondTemp RF generator
6 Ablation return pad 7 14-pin twist connector 8 GenConnect box (oriented up-side down, for purposes of
illustration)
9 Amplifier

10.4 Advanced Settings screen

The generator will first display the Advanced Settings screen (Figure 7) upon powering-up on the touch-screen display panel. This screen can also be accessed at any time during the procedure from the RF Ablation Treatment screen. The Advanced Settings screen allows for generator and pump settings to be established, for presets to be saved, and for a new case to be started for each patient. The default pump settings are 2 mL/min for low flow and 8 mL/min for high flow. A catheter does not need to be connected to the generator to use the Advanced Settings screen.
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Figure 7. Advanced Settings Screen

1 Low irrigation flow rate preset adjustment 2 High irrigation flow rate preset adjustment 3 Impedance cut-off set-point 4 Temperature set-point 5 Pump connection icon 6 Preset memory keys
7 Settings for Pre-Cool, Ramp Time, Duration and Post-Cool 8 “Treatment” button: touch to proceed to the Ablation
Treatment screen
9 “Set-up” button: touch to proceed to the Set-Up screen 10 Export data button 11 Start GenConnect auto calibration
The following ablation and flow rate parameters can be set up for the start of each case or established as a preset configuration. Recommended settings are defined in Table 1.
• GenConnect auto-calibration process (11, Figure 7): Press this button to initiate the auto-calibration feature. The system will detect absence or improper connection of a GenConnect unit or respective cable. When everything is properly connected, the system will complete the calibration process and activate the Treatment button (8). If the auto-calibration fails, or if it is not attempted, the Treatment button (8) is grayed out and further steps cannot be taken.
• Low and high irrigation pump flow rates, in mL/min (1, 2 in Figure 7): The value of the low irrigation flow rates can be set on the side of the Advanced Settings screen by using the up or down arrows to change the value of the flow rate for each box. The value of the high irrigation flow rate, which is only used during RF ablation, can also be set on the same screen.
Note: These functions will only be active (indicated by blue text) when communication is established between the generator and irrigation pump.
• Power set-point, in Watts: With DiamondTemp catheters, the generator operates only in temperature control mode. This means the generator controls the power level automatically, so that the temperature set-point is reached.
Note: The user cannot define or control the actual level of RF power delivered by the generator. A maximum power set-point is available and may be adjusted up or down using the arrows next to the Power display. During
temperature-controlled RF energy delivery, the generator automatically adjusts the power only up to levels equal to or less than this maximum power set-point. The recommended setting, which is also the default setting, is 50 W. By design, the generator cannot deliver more than 50 W.
• Temperature set-point, in Celsius (4, Figure 7): The value of the temperature control set-point can be established by turning the knob to the desired level.
• Timing for each stage of the ablation, in seconds (7, Figure 7): To adjust the timing for each stage of treatment, touch the button for the desired stage located below the graph in the center of the screen. Once selected, the active stage will be highlighted blue and the up and down arrows to the right can be used to increase or decrease the time increments in seconds.
– The pre- and post-cooling stages set the amount of time that the irrigation pump delivers irrigation before and after the ablation
to cool the tissue interface. No RF energy is delivered during the pre-cooling or post-cooling stage. At this stage, the generator will set the irrigation pump flow rate to “High”.
– The set-point for the duration of the ablation can also be established on this screen. This number can be set at 1 second
increments between 0 and 999 seconds.
12

Table 1. Recommended Generator and Irrigation Pump Settings

RECOMMENDED/DEFAULT GENERATOR SETTING
Operational Mode Temperature Control
Maximum Temperature Set-Point 60°C
Maximum Power Setting 50 W
Maximum Ablation Duration 45 seconds
DEFAULT PUMP SETTING
Irrigation Flow Rate during ablation 8 mL/min
Minimum continuous flow rate 2 mL/min
Preset memory keys
The generator has four (4) programmable preset memory keys (6, Figure 7), which can save and retrieve any desired combination of preset parameters. To program a preset memory key, first set up the desired preset values as previously described, then push and hold the preset key for 3 seconds. After holding the preset key for the required time, there will be an audible tone and the key will turn blue to indicate successful programming of the preset values. The saved preset parameters can be retrieved from the Advanced Settings screen or the Ablation Treatment screen by selecting the desired key. All presets are saved in the generator internal memory, even when the generator is powered down between cases.
Case ID and starting a new case
A case is defined as a set of ablations performed in a patient or in a particular chamber of the heart. A new case is started each time the generator is powered up, each time the new case button is selected. The generator saves relevant ablation parameters for each patient into a case file with this unique identifier (see “Exporting Data” for additional details on saving ablation data).
To proceed to the Ablation Treatment screen, touch the “Treatment” button (8, Figure 7) in the lower right corner of the screen. The Set-Up screen can also be navigated to by pressing the Set-Up icon (tools image, 9, Figure 7) at the bottom right-hand side of the Advanced Setting screen.
Exporting Data
Data from each ablation procedure is saved to the internal memory of the generator. Each unique case ID created will have a unique folder that stores the ablation data during the procedure. An external hard drive or memory stick with a USB connector can be connected to the USB port on the rear panel of the generator (4, Figure 3 ). Once connected, the “Export Data” button (10, Figure 7) will become active on the touch-screen display panel. Selecting this button will allow all data stored on the generator to be exported to the connected USB device. Exporting data should only be performed when the system is not in use. The generator has storage capacity for at least 1000 case files. Exporting the data does not clear the internal memory. If the internal memory reaches >80% capacity (on the Configuration screen), contact a Medtronic representative.

10.5 Configuration screen

The Configuration screen (Figure 8) can be accessed from either the Advanced Settings screen or the Ablation Treatment screen by pressing the Configuration icon at the bottom right-hand side of either screen (with the tools icon).
13

Figure 8. Configuration Screen

The Configuration screen allows the generator system and display preferences to be adjusted using the following buttons:
• Date and Time: Touch the part of the time or date to be changed. The active box will have a purple border. Press the up and down arrows to set the date and time. Time can be selected in 12-hour or 24-hour format.
Note: If the date and time setting reverts to a time in the past (e.g. Jan 01, 2003) when the generator is powered off, contact your Medtronic representative.
• Volume: Touch the green volume bar to set the desired volume.
• Brightness: Touch the yellow brightness bar to set the desired brightness.
• Language: Press the up and down arrows to choose a language. Note: Once a new language is selected, the generator will restart and display information in the new language.
• Save & Exit: Press to save and exit back to the prior screen.
• Cancel: Press the Cancel button to exit without saving changes.
The Configuration screen also displays the Generator Serial Number, Software Version, Date of Manufacture (DOM), and the percentage of memory available.

10.6 Contact Impedance screen

The Contact Impedance screen (Figure 9) can be accessed from the Advanced Settings screen. When a catheter is correctly connected to the generator, the text at the top center of this screen will change from “STANDBY” to “READY”, indicating that ablation may be performed. In READY mode, before initiating RF energy delivery, the Contact Impedance screen displays the tissue-contact impedance vs. time. This impedance may be utilized to monitor the level of contact between tissue and the RF electrode. A higher impedance value may indicate better tissue contact. However, caution should be exercised as other parameters, such as electrograms, fluoroscopic or intracardiac echo images, should also be monitored.
Figure 9 shows an example of the Contact Impedance when the electrode is in good contact with tissue. The real-time trace shows the history of tissue contact impedance over the previous 30 seconds.
Tissue contact impedance is not available during pre-cool, ablation, and post-cool phases. Once the RF START button is pressed, the front panel screen toggles to the Ablation Treatment screen (Section 10.7).
14

Figure 9. Contact Impedance Screen Displaying Impedance Trace

10.7 Ablation Treatment screen

The Ablation Treatment screen (Figure 10) can only be accessed from the Contact Impedance screen (Section 10.6), after the RF START button is pressed, or during READY mode by selecting the ‘Graph’ tab.

Figure 10. Ablation Treatment Screen

1 Real-time ablation parameter display 2 Ablation Temperature set-point (Celsius) 3 Ablation Duration set-point (seconds)
The Ablation Treatment screen displays the real-time parameters (irrigation flow rate, RF impedance, RF impedance relative change with respect to RF impedance start value, catheter highest temperature from all thermocouples, and ablation power and ablation duration) across the top of the screen in four boxes (1, Figure 10). On this screen, purple color indicates duration, green color indicates RF impedance, yellow color indicates power and orange color indicates temperature. The green Impedance field also includes the relative change in RF impedance during the course of RF delivery. The relative change is displayed as a signed percent variable (%) and it is computed relative to the initial value of RF impedance at the start of RF delivery. A change with a negative sign indicates a relative drop in RF impedance with respect to its initial value.
On the right-hand side of the Ablation Treatment screen, the top display section in the “Settings” segment is outlined in orange and labeled “Temperature,” if the generator is in temperature control mode (2, Figure 10). The temperature value represents the
4 Graphical display area 5 Message field
15
temperature set-point to be used during temperature control ablation. Rotating the knob adjusts the temperature set-point up or down. These settings can be adjusted at any point during the procedure.
The Duration set-point (3, Figure 10) displays the ablation duration set-point value in seconds. This value can be increased or decreased at any time during the procedure by using the up and down arrows located just below it. The maximum duration setting in the generator is 999 seconds. This time does not include the pre-cooling or post-cooling duration. An ablation will automatically terminate if this ablation duration set-point is reached.
Once correct communication has been established between the generator and the irrigation pump, irrigation flow rate levels can be selected by touching the desired level. The irrigation flow set-points for the low and high levels can be modified remotely with the generator by selecting the desired level and using the up and down arrows to modify the level to the desired value. With the communication link established, the generator will automatically switch the irrigation pump between the low and high flow rate before ablation, and then back down to the prior flow rate after the ablation has terminated. The irrigation flow from the pump can also be stopped by touching the “STOP PUMP” button on the touch-screen panel.
Note: When the communication link is established between the generator and irrigation pump, modifications to the flow rate or flow rate set-points on either the generator or pump will be enacted. Use the generator to control the irrigation pump during the procedure.
A preset memory value can also be selected by touching the desired preset button (6, Figure 7) to recall the stored preset value to one of the predetermined ablation settings. Selecting a preset will change the current ablation and flow rate preset values on the generator to those stored in the preset. If any of the values stored in the preset are changed on the generator after it is selected, the preset will become inactive and the generator functionality will default to the adjusted parameters.
To start an ablation at the selected values on the generator, press the green “Start” button located below the control knob on the front panel of the generator (8, Figure 4). Alternatively, the foot switch can be activated, if one is connected. Once the ablation duration set-point has been reached, the ablation will be stopped. To terminate an ablation sequence before reaching the duration set-point, press the red “Stop” button located above the control knob on the front panel of the generator (7, Figure 4) or alternatively, release the foot switch pedal. The ablation duration set-point will still remain at the current value. The ablation process can be restarted by pressing the “Start” button again. The top of the screen will display “RF ON”, and a constant audible tone will sound at all times while RF energy is being delivered.
Once an ablation is initiated, a real-time graph of the temperature, power, and impedance (in Celsius, Watt and Ohm, respectively, on the vertical axis) versus time (in seconds, on the horizontal axis) will be created in the “GRAPH” tab on the display screen (4, Figure 10). The real-time graph displays temperature in orange, power in yellow, and impedance in green.
The “ABLATION DATA” and “CASE DATA” tabs of the screen contain summary information on the following parameters (Table 2) for the current case:

Table 2. Ablation and Case Data Information

PARAMETER UNITS
Date NA Total number of ablations in procedure NA Total ablation time min Average ablation duration s RF power maximum W RF power average W Composite temperature range °C Composite temperature average °C RF Impedance start/end values Ω Maximum/Average RF impedance Ω Relative RF impedance change % Total infused fluid volume mL Tissue contact impedance maximum Ω Tissue contact impedance average Ω
To access this information, touch the “ABLATION DATA” tab (Figure 11) or “CASE DATA” tab (Figure 12) to make it active (indicated by a blue highlighting of the tab). This will display a summary of the case and ablation information in the area where the ablation graph was located. Additionally, a summary of parameter values reached during the last ablation is also provided. The Last Ablation summary provides data about: Mode (such as Temperature control), last ablation duration, power, impedance, temperature and contact impedance values. To return to the graph, touch the tab labeled “GRAPH”. If any ablation is started while the tab is active, the display window will automatically switch back to the graph display.
16

Figure 11. Ablation Data Tab

Figure 12. Case Data Tab

From the Ablation Treatment screen, it is possible to access the Advanced Settings screen by selecting the “Advanced Settings” button at the lower-left corner of the screen. It is also possible to access the Configuration screen from the Ablation Treatment screen by selecting the Configuration screen icon at the lower-right corner of the screen.

10.8 Indicators and informational messages

During the procedure, informational messages are displayed in a separate pop-up window or in the message field (5, Figure 10) at the bottom of the touch-screen display on the generator. The displayed message contains an error code, an error message, and (for some errors) recommended actions. Table 3 shows informational messages that may occur during use with recommended actions. Table 4 shows messages that do not have actions for the user to perform. For these messages, if it cannot be cleared, power down and restart the generator. Report to Medtronic if the condition occurs repeatedly.
Some messages may indicate that there has been a hardware or software undesired operating condition of the generator. In addition, the red indicator light on the upper-right front panel of the generator will turn on. If such an informational message occurs during operation, attempt to restart the generator using the soft power on/standby switch on the front panel of the generator.
17
The informational messages are displayed with an error code (such as, E1003, P3032, or W110). The codes are useful for advanced engineering troubleshooting. If it is necessary to call a Medtronic representative for support, it can be helpful to provide the error code to the engineering team. If an error code is seen that is not listed in the tables below, contact a Medtronic representative.

Table 3. Generator Codes, Message Descriptions, and Recommended Actions

Error Code Error Message Recommended Action
E1002 EEPROM COMMUNICATION FAILURE Disconnect and reconnect catheter cable.
If problem persists, replace catheter. E1003 EXPIRED CATHETER Replace catheter. E1006 FOOTSWITCH FAILURE Disconnect and reconnect the Foot
Switch. If problem persists, replace the
Foot Switch.
E1007-E1010 PUMP CONNECTION FAILURE Check RFG-Pump connection.
E1014 MISSING RETURN PAD Plug in or replace the return pad. If problem
persists, cycle power to the Generator.
E1015 MISSING CATHETER Plug in or replace catheter. If problem per-
sists, replace the Foot Switch.
E1022 DISK SPACE LOW Contact a Medtronic representative to free
up disk space.
E1023 DISK SPACE FULL Contact a Medtronic representative to free
up disk space.
E1024, E1053, E1059 LOW IMPEDANCE Recheck all cable, return pad, and catheter
connections. If problem persists, reboot
the RFG. If problem persists, replace cath-
eter, cables, or return pad.
E1025 UNSUPPORTED ADAPTER CABLE Disconnect and reconnect catheter cable.
If failure recurs, replace catheter cable.
E1030, E1032 PUMP NOT DELIVERING Check RFG to Pump connection. Discon-
nect and reconnect Ethernet cable. If prob-
lem persists, reboot the Pump.
E1031 PUMP FLOW RATE LOW Check RFG to Pump connection. Discon-
nect and reconnect Ethernet cable. If prob-
lem persists, reboot the Pump. E1033 PUMP GENERATED ERROR Refer to the Pump manual. E1034 EEPROM DATA INVALID Disconnect and reconnect catheter. If fail-
ure recurs, replace catheter.
E1036 GEN CONNECT NO CALIBRATION Disconnect and reconnect the GenCon-
nect Cable. Perform GenConnect calibra-
tion. If problem persists, replace GenCon-
nect Cable and/or Generator Connection
Box E (or EPT GenConnect Box). Perform
GenConnect calibration again. E1037 RF OVER TEMPERATURE Catheter may need replacement. E1038 GEN CONNECT CALIBRATION FAILED Disconnect and reconnect the GenCon-
nect Cable. Perform GenConnect calibra­tion. If problem persists, replace GenCon­nect Cable and/or GenConnect Box). Per-
form GenConnect calibration again. If
problem persists, reboot the RFG.
E1044 PUMP NOT PRESENT Disconnect and reconnect the Ethernet
cable to the Pump and RFG. Reboot Pump
and RFG. If problem persists, replace the
Ethernet cable.
E1045 RF TRANSITION PUMP NOT PRESENT Disconnect and reconnect the Ethernet
cable to the Pump and RFG. Rebook
Pump. If problem persists, replace the
Ethernet cable.
E1046-E1051 TEMPERATURE SENSOR FAILURE Replace the catheter.
18
Table 3. Generator Codes, Message Descriptions, and Recommended Actions (continued)
Error Code Error Message Recommended Action
E1052 TEMPERATURE ABOVE SET POINT Check irrigation flow. Replace catheter if
E1054 EXCESSIVE DELIVERY TEMPERATURE Catheter may need replacement. E1055 TEMPERATURE LIMIT REACHED Catheter may need replacement. E1056 IMPEDANCE OUT OF RANGE Recheck all cable, return pad, and catheter
connections. If problem persists, reboot
the RFG. If problem persists, replace cath-
E1057 LOW IMPEDANCE Catheter may need replacement.
E1058, E1060, E1065 HIGH IMPEDANCE Cables may be disconnected, check con-
E1061 PUMP FLOW OFF Turn on flow. E1066 NO VALIDATED CATHETER Disconnect and reconnect catheter. If
problem persists, replace the catheter.
E1067 High RF current limit exceeded at return
pad
Confirm adequate return pad contact to
patient. Ablation may start once Heating Factor falls below 30 A2s (message W05 is cleared). For more information on ablation
duration and power settings, see Sec-
E1068 High RF current limit exceeded - wait to
start ablation
Confirm adequate return pad contact to
patient. Ablation may start once Heating Factor falls below 30 A2s (message W05 is cleared). For more information on ablation
duration and power settings, see Sec-
F2999 Unrecoverable software failure. Shut down
the system via the rear power switcha.
W05 RF current high at return pad - RF output
limited
Restart the system after shutting down. If
problem persists, contact Medtronic.
Confirm adequate return pad contact to
patient. For more information on ablation
duration and power settings, see Sec-
W102, W104 LOSS OF TISSUE CONTACT Reposition catheter for better contact.
W105-W109 LOSS OF CONTACT Reposition catheter for better contact.
W103 IMPEDANCE OUT OF RANGE Catheter tip electrode may be inside intro-
ducer sheath. Reposition catheter or
W110-W111 INEFFICIENT IRRIGATION Check pump flow or catheter contact to tis-
sue. Replace catheter and irrigation tube if
a
This message is displayed only in English.
condition persists.
eter, cables, or return pad.
nections.
tion 16.4.
tion 16.4.
tion 16.4.
check catheter connectivity.
necessary.

Table 4. Generator Codes and Message Descriptions

Error Code Error Message
E1004-E1005 CURRENT DISCREPANCY
E1026 EXCESSIVE RF OUTPUT CURRENT E1027 EXCESSIVE RF FORWARD POWER E1028 EXCESSIVE RF VOLTAGE E1035 RAMP SET POINT DISCREPANCY E1039 MEASURED POWER E1042 RF POWER DISCREPANCY
E1062-E1063 VOLTAGE LIMIT EXCEEDED
F2001 ADAPTOR F2004 EXCESSIVE SUPPLY CURRENT
19
Table 4. Generator Codes and Message Descriptions (continued)
Error Code Error Message
F2005 EXCESSIVE SUPPLY VOLTAGE
F2010 OPERATING REFERENCE FAILURE P3001-P3004 REFERENCE FAILURE P3005-P3012 TOUCH SCREEN FAILURE
P3013 FOOTSWITCH FAILURE
P3014 STUCK ON FOOTSWITCH FAILURE
P3017, P3021, P3037-P3038 INTERNAL LOAD TEST FAILURE
P3032, P3035-P3036 SOFTWARE FAILURE
P3039-P3044 SELF TEST FAILURE
P3045 POST CONTACT INDICATION LOAD
P3046 POST CONTACT INDICATION PHASE
P3047 STUCK RF ON BUTTON

10.9 Operation sequence for the generator

1. Before operation, the generator must be placed on a stable surface with adequate circulation of air around the device to avoid overheating. Additionally, the generator must be protected from moisture, contamination, and contact with flammable or explosive substances.
2. Plug in and turn on the generator.
3. Create and check all connections. Note: The generator will recognize the catheter when the correct connection is made with the appropriate catheter-to-RFG
cable. Refer to the message bar for information on any missing connections. It is not required to notify the generator or select the type of catheter connected.
4. Verify that the generator and irrigation pump are communicating by noting that the communication icon on the top of the generator touch screen is illuminated.
5. Verify that the irrigation pump is fully operational, according to the irrigation pump user manual.
6. On the Advanced Settings screen, configure any procedure parameters, as desired. Use caution and sound medical reasoning when deciding to change any of these parameters. Maximum continuous ablation duration at a single site should not exceed 60 s.
Note: To start a new procedure immediately after a prior one without turning off the generator, press the “NEW CASE” button on the generator touch screen.
7. Check or modify any of the preset memory keys, if desired.
8. Enter patient information.
9. Touch the GenConnect auto-calibration button and wait until this process completes successfully.
10. Touch the configuration icon at the bottom right corner of the Advanced Settings screen to advance to the Configuration screen.
11. Ensure the generator configuration preferences are accurate. Modify configuration preferences, if desired.
12. Touch the “SAVE & EXIT” button at the bottom right corner of the generator touch screen to return to the Advanced Settings screen.
13. When the preceding steps are complete, touch the “TREATMENT” button on the Advanced Settings screen to begin the procedure.
14. Ensure that the generator displays “READY” in the top center field shaded green on the screen.
15. The generator enters the Contact Impedance screen. Monitor the electrode-tissue contact so that it is suitable for the goals of the procedure.
16. Use the controls of the generator to establish the desired irrigation flow rate through the catheter. See the DiamondTemp catheter and irrigation pump instructions for full information on setting up and operating the irrigation pump, as well as appropriate irrigation flow rates during the ablation procedure.
Note: When communication is established between the two devices, modifications to the flow rate or flow rate set-points on either the generator or pump will be enacted. Use the generator to control the irrigation pump during the procedure.
Note: It is recommended that the controls of the irrigation pump only be used in three cases: (1) during initial flush of the tubing set and preparation of the catheter, (2) if air bubbles are detected in the tubing set, and (3) in case of an urgent need to change the irrigation flow rate or stop the irrigation pump. Refer to the irrigation pump user manual for full information on set-up and operation of the pump.
17. Set the desired ablation parameters on the generator or select the desired preset memory key. Use caution and sound medical reasoning when deciding to change any of these parameters. Maximum continuous ablation duration at a single site should not exceed 60 s.
20
Note: Read the complete DiamondTemp catheter manual for full instructions for use of the catheter, including ablation settings.
18. To start an ablation at the selected values on the generator, press the green “Start” button located below the control knob on the front panel of the generator. If the ablation duration set-point has been reached, the current ablation will be stopped. To terminate an ablation sequence before reaching the duration set-point, press the red “Stop” button located above the control knob on the front panel of the generator. The ablation duration set-point will still remain at the current value.
Note: During an ablation, the programmed set-points for the ablation temperature level and duration can be adjusted, without interrupting the ablation process, by using the knob or duration up and down keys, respectively.
Note: With the communication link established between the irrigation pump and generator, the high irrigation flow rate used for ablation will be initiated automatically. After the ablation termination and the post-cooling phase, the irrigation pump will automatically return to the irrigation flow rate that was on before the start of that ablation.
19. To restart subsequent ablations, first ensure that the appropriate ablation settings are displayed on the generator touch screen. The ablation process can be initiated again by pressing the “Start” button on the generator front panel.
20. After the desired therapy has been delivered to the patient and the DiamondTemp catheter has been removed, the irrigation flow may be stopped by touching the “Stop Pump” button on the touch-screen display.
21. Procedural ablation parameter data is automatically saved to the internal memory of the generator. To export this data after the case, return to the Advanced Settings screen and connect an external hard drive or memory stick with a USB connector to the USB port on the rear panel of the generator. Once connected, the “Export Data” button will become active on the touch-screen display. Selecting this button will allow all data stored on the generator to be exported to the connected USB device.
22. Unless otherwise instructed by an on-screen message, the device should be powered down by first pressing the soft power button on the front panel, not the rear power switch. Once the device returns to standby mode (front panel button illuminated amber in color), the device may be completely powered off by switching the rear panel power switch to the 0 position.

11 DiamondTemp ablation system architecture and cybersecurity

Figure 13. DiamondTemp Ablation System Architecture Diagram

1 Specially Configured Maintenance USB Thumb Drive 2 USB Port 3 Power Cable 4 RS-232 Output to EP Recording System 5 Static IP Output only Ethernet Port 6 RF Generator 7 Logged Measurements 8 Program & Settings 9 Pump Control port
The DiamondTemp generator and irrigation pump devices are not intended for use on or to be connected to a computer network and do not accept wireless or unknown physical connections. A system architecture diagram for the DiamondTemp ablation system is presented in Figure 13. The Pump Control port is dedicated only for communications between the DiamondTemp generator and DiamondTemp irrigation pump. The USB port is used to export data when the system is not in use.
10 CAT 5 Cable (Pump Flow Rate Commands &
Acknowledgements) 11 Irrigation Pump 12 Motor 13 Saline Bag 14 Irrigation Tubing 15 Patient 16 Catheter
21
Any suspected compromise of the DiamondTemp ablation system’s cybersecurity, from such events as unauthorized access, computer virus infection, or inadvertent connection to a network, should be reported to Medtronic. A proper course of action, determined by Medtronic and the end user, should be determined before the system can be further used.
Software upgrades are to be performed only by Medtronic or authorized personnel. The DiamondTemp ablation system contains the following commercial, open source, or off-the-shelf software:
• QT Third party graphics library
• ALSA Linux Sounds generation library
• SQLite Database Interface library
• Customized Linux Operating System including TCP/IP stack

12 Maintenance and service

12.1 Cleaning

The DiamondTemp generator must be protected from moisture, contamination, and contact with flammable or explosive substances. The generator and foot switch surface may be cleaned with non-flammable and non-explosive agents only, according to the following steps. Follow universal precautions for protective apparel when handling and cleaning contaminated instruments. Make sure no fluids or moisture enter the interior of the generator during cleaning.
1. Before cleaning, turn off the generator. Disconnect the power cord from the electrical power source and from the rear of the generator. Disconnect all other cables and peripherals.
2. Wipe the generator enclosure with a clean, soft, nonlinting cloth dampened with a pH neutral detergent.
3. Wipe again with distilled or sterilized water.
4. Wipe dry with a clean, soft, nonlinting cloth.
5. To disinfect, use broad spectrum disinfectants like phenolics, aldehydes, or alcohols. Recommended disinfectants are Glutaraldehyde 1%, 70% IPA, sodium hypochlorite (0.1%) or equivalent. Follow the manufacturer’s instruction for use to use the disinfectant.
Do not immerse the generator in any liquid or expose the generator to steam autoclave or ethylene oxide (EtO) sterilization. For instructions on the use, cleaning, or sterilization of any accessory cables to the generator, refer to the cable instructions.

12.2 Maintenance

There are no user-serviceable parts in the generator, except as noted in the instructions below. The generator requires no adjustments, calibrations, or regularly-scheduled maintenance.
While maintenance is not required, local standards and regulations should be followed with respect to periodic performance verification. If the generator requires repairs or is defective, the unit should be returned to the manufacturer for service or replacement. Contact a Medtronic representative for details.

12.3 Replacing fuses

To replace a fuse in the generator:
1. Remove the power cord.
2. Use a small blade screwdriver or similar tool to unlatch the fuse holder door at the top of the fuse holder.
3. Use a small blade screwdriver or similar tool to remove the red fuse block from the fuse holder.
4. Remove the defective fuse(s) and replace with the correct size, rating, and type (replace with Littelfuse 2183.15P or equivalent). To avoid the risk of fire, use only the specified fuse.
5. Reinstall the fuse block, close the fuse holder door, and reinstall the power cord.
6. Switch on the RF generator and confirm it powers up.

13 Storage

Disconnect the generator from a power source for long-term storage. For additional storage information, see Section 16.9
22

14 Disposal

Refer to local requirements regarding the disposal of the generator and accessories.

15 Guidance and manufacturer’s declarations

Table 5. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The generator is intended for use in the electromagnetic environment specified below. The customer or the user of the generator should assure that it is used in such an environment.
Emissions Test Compli-
ance
RF emissions CISPR11
RF emissions CISPR11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/flicker emissions IEC 61000-3-3
Table 6. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The generator is intended for use in the electromagnetic environment specified below. The customer or the user of the generator
should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge (ESD)
IEC 61000-4-2 ±2 kV, ±4 kV, ±8 kV,
Electrical fast transi­ent/burst
IEC 61000-4-4 ±2 kV @ 100 kHz repeti-
Surge Power inputs: Power inputs: Mains power quality should be that of a typical com-
IEC 61000-4-5 ±0.5 kV, ±1 kV, ±2 kV
Voltage dips, short inter­ruptions and voltage var­iations on power supply input lines
IEC 61000-4-11 0% UT; 1 cycle and
Note: UT is the a.c. mains voltage before application of the test level.
Power frequency (50/60 Hz) magnetic field
IEC 61000-4-8 50 Hz or 60 Hz 50 Hz or 60 Hz
±8 kV contact ±8 kV contact Floors should be wood, concrete or ceramic tile. If
±15 kV air ±2 kV @ 100 kHz repeti-
tion frequency for power supply lines
tion frequency for input/output lines
±0.5 kV, ±1 kV Line-to­Line
Line-to-Ground Signal input/outputs: Signal input/outputs: ±2 kV Line-to-Ground ±2 kV Line-to-Ground Voltage Dips: Voltage Dips: Mains power quality should be that of a typical com­0% UT; 0.5 cycle 0% UT; 0.5 cycle At 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315° phase angles
70% UT; 25/30 cycles Single phase: at 0° Single phase: at 0° Voltage interruptions: Voltage interruptions: 0% UT; 250/300 cycle 0% UT; 250/300 cycle
30 A/m 30 A/m Power frequency magnetic fields should be at levels
Group 1 The generator must emit electromagnetic energy in order
Class A The generator is suitable for use in all establishments
Class A
Complies
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±2 kV @ 100 kHz repeti­tion frequency for power supply lines
±2 kV @ 100 kHz repeti­tion frequency for input/output lines
±0.5 kV, ±1 kV Line-to­Line
±0.5 kV, ±1 kV, ±2 kV Line-to-Ground
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° phase angles
0% UT; 1 cycle and 70% UT; 25/30 cycles
Electromagnetic environment—Guidance
to perform its intended function. Nearby electronic equip­ment may be affected.
other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
floors are covered with synthetic material, the rela­tive humidity should be at least 30%.
Mains power quality should be that of a typical com­mercial or hospital environment.
mercial or hospital environment.
mercial or hospital environment. If the user of the generator requires continued oper-
ation during power mains interruptions, it is recom­mended that the generator be powered from an uninterruptible power supply or battery.
characteristic of a typical location in a typical com­mercial or hospital environment.
23
Table 6. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (continued) Conducted RF
IEC 61000-4-6
Radiated RF EM Fields including proximity fields
0.15 MHz – 80 MHz 3 V, 80 % AM at 1 kHz
ISM bands between
0.15 MHz and 80 MHz 6 V, 80 % AM at 1 kHz
0.15 MHz – 80 MHz 3 V, 80 % AM at 1 kHz
ISM bands between
0.15 MHz and 80 MHz 6 V, 80 % AM at 1 kHz
Mains power quality should be that of a typical com­mercial or hospital environment.
Band (MHz) Wireless Service Immunity Test Level
(V/m)
Compliance Test Level
(V/m)
from RF wireless com­munications equipment
IEC 61000-4-3
150 kHz – 80 MHz General < 3 < 3 80 MHz – 2.7 GHz General 3 3
380 – 390 TETRA 400 27 27 430 – 470 GMRS 460, FRS 460 28 28 704 – 787 LTE Band 13, 1 9 9 800 – 960 GSM 800/900,
28 28
TETRA 800, iDEN 820,
CDMA 850, LTE Band 5
1,700 – 1,990 GSM 1800; CDMA 1900;
28 28 GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS
2,400 – 2,570 Bluetooth, WLAN,
28 28
802.11 b/g/n,
RFID 2450, LTE Band 7
5,100 – 5,800 WLAN 802.11 a/n 9 9
Portable and mobile RF communications equipment should be used no closer to any part of the generator including cables, than the recommended separation distance calculated from the equation:
d=6/E×√P Where:
d is the separation in meters P is the maximum output power rating of the transmitter in watts (W) according to the manufacturer E is the Compliance Test Level indicated above.
Interference may occur in the vicinity of equipment marked with the following symbol:
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the generator or any of its components are used exceeds the applicable RF compliance level above, the generator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating components or the generator.
b
Within the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 7. Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Generator The generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer
or the user of the generator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the generator as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power
of transmitter
(W)
150 kHz to 80 MHz
d = 1.2√P
Separation distance according to frequency of transmitter
(m)
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.2√P
d = 2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73 1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
24
Table 7. Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Generator (continued)
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 – At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.

16 Technical specifications

16.1 Mains input

• Input voltage/current/frequency: 100 - 240 Vac / 2.5 A - 1.4 A / 50/60 Hz

16.2 Fuses

• Replace fuses with Littelfuse 2183.15P or equivalent

16.3 RF output

• RF frequency: 460 kHz ± 1%, quasi-sinusoidal
• Max rated power: 50 W into 50 – 288 Ω load
• Maximum current: – Heating Factor of 0-30 A2s: 1 ARMS – Heating Factor of >30 A2s: 0.8 ARMS
• Maximum voltage: 120 V
• Maximum Heating Factor generated in any 60 second period: 40 A2s
RMS

16.4 Heating Factor

This generator model contains software that tracks RF current (A) applied to the return pad from the catheter tip over the duration of the ablation. This parameter is called ‘Heating Factor’ with units A2seconds (A2s).
Heating Factor calculations are tied to informational messages W05, E1067, and E1068 in Table 3. Full RF output current (1 ARMS) is allowed when Heating Factor is less than 30 A2s. Current output is reduced to 0.8 ARMS when Heating Factor goes above 30 A2s, in alignment with emission of W05 warning message. RF ablation is terminated when Heating Factor reaches 40 A2s (error E1067) and may not commence again until Heating Factor drops below 30 A2s (message W05 is cleared) to allow for heat dissipation at the return pad site.
Extended duration of high RF power output may result in excessive heating of the skin at the return pad site. To reach the maximum power set-point, current is modulated based on RF impedance. For an example of this relationship and its effect on Heating Factor see Table 8. At lower RF impedance values, higher current is required. At higher RF impedances, lower current is required, and the warning and error messages will not be seen (N/A in Table 8).

Table 8. Heating Factor and Current Limitations

Single Ablation Parameters
Maximum RF Power (Watts) Average RF Impedance (Ω) W05 (Heating Factor 30 A2s) E1067 (Heating Factor
50 60 36 51.6 50 80 48 N/A 50 100 60 N/A 50 101 and above N/A N/A 40 55 41.3 56.9 40 80 60 N/A 40 81 and above N/A N/A
Duration to warning / error (seconds)
40 A2s)

16.5 Electrical safety

• IEC 60601 Class 1 equipment
• Rated for continuous operation
• Accessory rated voltage: 120 V
minimum
RMS
25
• Applied parts classification – Catheter - type CF defibrillation-proof – Neutral (Indifferent/Return) Electrode – type F high frequency isolated

16.6 Settings

• Temperature: 40°C to 80°C
• RF Power: 0 to 50 Watts
• RF On Time: 0 to 999 seconds
• RF Ramp Time: 0 to 30 seconds

16.7 Measurement accuracy

• Temperature: ± 1.5 °C
• Power: ± 7% or ± 2 W of setting
• Impedance: ± 10% or ± 5 Ω whichever is greater from 35 to 300 Ω
• Time: ± 1 sec of setting

16.8 Mechanical specifications

• Size: 38 cm x 45 cm x 22 cm
• Weight: less than 11 kg
• Foot switch cable length: 355 cm ± 15 cm
Moisture protection rating
The generator and foot switch comply with the following international electrical safety ratings with regard to water as required by IEC 60601-1:
• Generator: IPX0, not water resistant
• Foot switch: IPX8, immersion resistant

16.9 Environmental specifications

• Note: Allow the system to equilibrate to room temperature for a minimum of 4 hours if the system has been stored at temperatures outside of the operational temperature range.
• Operational temperature: 15°C to 30°C (59°F to 86°F)
• Operational humidity: 30% to 75% relative humidity (noncondensing)
• Operational pressure: 70 to 106 kPa
• Storage temperature: 15°C to 30°C (59°F to 86°F)
• Stacking height: Maximum of two shipping boxes on top of each other

16.10 Output power curves

Figure 14. Power vs. Impedance RF Generator

26
1 Power [W] 2 Impedance [Ω]
3 Full Power vs. Impedance 4 Half Power vs. Impedance

17 Limited warranty

The following limited warranty applies to customers within the United States only: A. This limited warranty provides the following assurance to the customer of the Medtronic DiamondTemp RF generator, irrigation
pump, GenConnect cable, and EGM cable, with reusable parts (foot switch, ethernet cable, and power cord), hereafter collectively referred to as the DiamondTemp ablation system. Subject to the limitations herein, Medtronic warrants the DiamondTemp ablation system sold to the customer will be free from defects in materials and workmanship under normal usage for a period of 12 months from the delivery date at the customer’s facility.
B. Should the DiamondTemp ablation system fail to meet the above warranty, Medtronic will at its option, repair or replace such DiamondTemp ablation system, or any portion thereof. For the limited warranty to apply, the following conditions must be met:
(1) Medtronic must be notified of and confirm the failure of the alleged defect within 60 days after discovery of the defect.(2) The DiamondTemp ablation system must not have been repaired or altered outside of authorized personnel at Medtronic.
(3) THE DIAMONDTEMP ABLATION SYSTEM MUST BE USED IN ACCORDANCE WITH LABELING AND NOT ALTERED OR SUBJECTED TO MISUSE, ABUSE, IMPROPER HANDLING, OR ACCIDENT, INCLUDING, BUT NOT LIMITED TO, FIRE, FLOOD OR NATURAL DISASTERS.C. At the discretion of Medtronic, parts or assemblies used or installed as part of the DiamondTemp ablation system may be either new or rebuilt of equal or improved quality. All parts removed or replaced during maintenance become the property of Medtronic.
D. This limited warranty is limited to its express terms. In particular: (1) Except as expressly provided by this limited warranty, MEDTRONIC EXPRESSLY DISCLAIMS ANY REPRESENTATION OR
WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WHETHER AS TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ANY OTHER MATTER. THE REMEDIES SET FORTH IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES AVAILABLE TO THE CUSTOMER OR ANY THIRD PARTY FOR BREACH OF WARRANTY. MEDTRONIC SHALL HAVE NO LIABILITY TO ANY PERSON FOR INCIDENTAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES OF ANY DESCRIPTION, WHETHER ARISING OUT OF WARRANTY, OTHER CONTRACT, TORT, OR OTHERWISE.
(2) Except as expressly provided by this limited warranty, MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, MALFUNCTION, OR FAILURE OF THE DEVICE TO FUNCTION WITHIN NORMAL TOLERANCE, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE.
E. The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this limited warranty is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the limited warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this limited warranty did not contain the particular part or term held to be invalid. This limited warranty gives the customer specific legal rights. The customer may also have other rights that vary from state to state.
F. No person has any authority to bind Medtronic to any representation, condition, or warranty except this limited warranty. G. This limited warranty is not applicable to accessories or products used with the DiamondTemp ablation system unless specifically
noted.

18 Glossary of symbols

The following table defines symbols that are used on packaging and product labeling. Refer to the labels to determine which symbols apply to this product and for the product-specific information, such as the date of manufacture.
Symbol
Standard/Standard title or reference
21 CFR 801.109
ISO 15223-1
EN 50419
IEC 60601-1
a
d
b
c
Symbol title/Reference num­ber Explanatory text
Prescription only USA Federal law restricts this
device to sale by or on the order of a licensed healthcare practi­tioner.
Consult instructions for use (clause 5.4.3)
Consult instructions for use at this website: www.medtronic.com/manuals
Recycle: Electronic Equipment Do NOT throw in trash
Follow instructions for use (Table D2, Symbol 10)
Refer to instruction man­ual/booklet (blue symbol)
27
Symbol
Standard/Standard title or reference
ISO 15223-1
d
Symbol title/Reference num­ber Explanatory text
Catalog number (clause 5.1.6)
Indicates the manufacturer’s catalog number so the device can be identified
ISO 15223-1
d
Serial number (clause 5.1.7)
Indicates the manufacturer’s serial number so that the device can be identified
ISO 15223-1
N/A Manufactured in/ manufactur-
ISO 15223-1
d
Manufacturer (clause 5.1.1)
Indicates the medical device manufacturer
Indicates where the device was
d
Date of manufacture (clause 5.1.3)
ing site
manufactured Indicates the date when the
medical device was manufac­tured
ISO 15223-1
d
Keep dry (clause 5.3.4)
Indicates a medical device that needs to be protected from moisture
ISO 15223-1
d
Do not use if package is dam­aged (clause 5.2.8)
Indicates a medical device that should not be used if the pack­age has been damaged or opened
ISO 15223-1
d
Temperature limit (clause 5.3.7)
Indicates the temperature limits to which the medical device can be safely exposed
N/A Storage temperature limit Indicates the required temper-
ature range for storing the device
N/A Transit temperature limit Indicates the required temper-
ature range for transporting the device
ISO 15223-1
d
Humidity limitation (clause 5.3.8)
Indicates the range of humidity to which the medical device can be safely exposed
ISO 15223-1
d
Atmospheric pressure limita­tion (clause 5.3.9)
Indicates the range of atmos­pheric pressure to which the medical device can be safely exposed
ISO 7000
ISO 7000
e
e
Non-ionizing electromagnetic radiation (symbol 5014)
Stacking limit by number (symbol 2403)
To indicate elevated, potentially dangerous, levels of non-ioniz­ing radiation
To indicate that items shall not be vertically stacked beyond the specified number
ISO 7000
e
Equipotentiality (symbol 5021)
To identify the terminals which, when connected together, bring the various parts of an equip­ment or of a system to the same potential, not necessarily being the earth (ground) potential, e.g. for local bonding
ISO 7000
ISO 7000
e
e
Foot switch (symbol 5114)
Alternating current
To identify a foot switch or a connection for a foot switch
Alternating current
(symbol 5032)
ISO 7000
e
Defibrillation Proof Type CF Applied Part (symbol 5336)
To identify a defibrillation-proof type CF applied part complying with IEC 60601-1.
28
Symbol
Standard/Standard title or reference
ISO 7000
ISO 7000
e
e
Symbol title/Reference num­ber Explanatory text
Stand by (symbol 5009)
OFF
Power in Standby (lit amber) or ON (lit green)
Power OFF
(symbol 5008)
ISO 7000
e
ON
Power ON
(symbol 5007)
N/A N/A Fuses
N/A N/A EGM Output – Filtered
ECG / Pace
N/A N/A Video Output
N/A N/A Serial Output
N/A N/A Service Communication port
(not for clinical use)
N/A N/A Remote Control port (for future
generation use)
N/A N/A Pump Control port
N/A N/A USB port (when system is not in
use)
N/A N/A Catheter connection
N/A N/A Neutral Electrode connection
N/A N/A Floating Neutral Electrode con-
nection
IEC 60529
IEC 60529
f
f
International Protection (IP) Code
International Protection (IP) Code
Indicates the product is not water resistant (generator)
Indicates the product is able to be submerged in water (foot switch)
N/A Package contents Indicates the components
included in the device package
N/A Generator Indicates that the type of device
is RF generator
N/A Accessories Indicates that accessories are
included in the device package
ISO 7000
e
Product documentation (symbol 0419)
Indicates that product docu­mentation is included in the device package
N/A N/A Indicates the device Stop but-
ton (red symbol)
N/A N/A Indicates the device Start but-
ton (green symbol)
N/A N/A Power cord
ISO 15223-1
d
Lot number (clause 5.1.5)
Indicates the manufacturer’s lot number so that the lot can be identified
29
Symbol
Standard/Standard title or reference
ISO 15223-1
d
Symbol title/Reference num­ber Explanatory text
Fragile, handle with care (clause 5.3.1)
Indicates the device is fragile and should be handled with care
N/A Compliance mark Indicates conformance to appli-
cable standards
a
21 CFR 801.109: United States Code of Federal Regulations, Title 21, Food and Drugs
b
EN 50419: Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE)
c
IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
d
ISO 15223-1: Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied
e
ISO 7000: Graphical symbols for use on equipment
f
IEC 60529: Degrees of protection provided by enclosures (IP Code)
30
Medtronic, Inc.
*M005668C001*
710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000
© 2021 Medtronic M005668C001 A 2021-02-02
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