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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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