Medtronic CEDTP100 User’s Manual

DiamondTemp™ CEDTP100

Irrigation Pump

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™

1 Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2 Contents of package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

5 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

6 Potential adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

7 Unpacking the irrigation pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

8 Setting up the irrigation pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

8.1 Electrical connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

8.2 Turning on the irrigation pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

8.3 Loading the tubing set in the irrigation pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

8.4 Preparing for irrigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

9 Working with the system controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

9.1 Touch-screen display and irrigation flow control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

9.2 Set-up screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

10 Irrigation pump operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

11 Indicators and informational codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

12 DiamondTemp ablation system architecture and cybersecurity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

13 Maintenance and service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

13.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

13.2 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

13.3 Irrigation pump flow rate verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

13.4 Replacing fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

14 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

15 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

16 Guidance and manufacturer’s declarations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

17 Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

18 Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

19 Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

20 Glossary of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

1 Device description

The Medtronic DiamondTemp irrigation pump (model CEDTP100) is part of the DiamondTemp ablation system, which also includes the DiamondTemp ablation catheter, DiamondTemp RF generator, DiamondTemp catheter-to-RF generator cable, DiamondTemp GenConnect cable, DiamondTemp Generator Connection Box E, DiamondTemp EGM cable, DiamondTemp irrigation tubing set, and optional DiamondTemp foot switch.

The irrigation pump delivers heparinized normal saline to the catheter through a tubing set by a peristaltic mechanism employing rollers and mechanical fingers that push saline through the tubing set.

The irrigation pump is intended to be used in an electrophysiology (EP) lab. It is not sterile and is intended to reside outside the sterile field.

The DiamondTemp ablation system is designed to deliver radiofrequency (RF) energy to the cardiac anatomy via the DiamondTemp catheter. The DiamondTemp irrigation pump (Figure 1) delivers saline (0.9%) with Heparin at 1 IU/mL to the catheter when used in conjunction with the DiamondTemp tubing set. The irrigation pump has a touch-screen display and flow control button that controls a two-flow-rate feature for easy selection of the appropriate irrigation flow rate. The rate can be changed between a low flow rate (1-5 mL/min) and a high flow rate (6-30 mL/min). Large numbers on the touch-screen display and an LED light on the flow control button indicate the flow rate selected. The irrigation pump communicates with the DiamondTemp generator and may be operated independently or under control of the generator.

Figure 1. DiamondTemp Irrigation Pump

1 Touch Screen Display 2 Flow-Rate Control Buttons 3 Pump Head

A transparent pump head door protects the rotating pump head, while allowing visibility of the entire tubing set during pump operation. The tubing set is placed in the path and around the pump head for operation. The irrigation pump uses twin ultrasonic air bubble

sensors for added safety in detecting air infusion. Audible or visual indicators and informational messages displayed on the touch-screen display warn of air in the tubing, an open pump

head door, or other operational conditions.

4 Pump Head Door 5 Air Bubble Sensors

2 Contents of package

The DiamondTemp irrigation pump is supplied nonsterile and is not intended for sterilization. The package contains the following items:

• One model CEDTP100 irrigation pump

• One power cord

• One Ethernet cable (to connect the pump to the generator)

• Product documentation

3 Indications for use

The DiamondTemp irrigation pump 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 irrigation pump.

4 Contraindications

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

5 Warnings and precautions

• Carefully read all DiamondTemp ablation system (catheter, generator, catheter-to-RFG cable, GenConnect cable, Generator Connection Box E, EGM cable, irrigation pump, tubing set, and optional foot switch) instructions before use. Observe all contraindications, warnings, and precautions noted in the directions. Failure to do so may result in patient complications. Review any applicable product information with the patient, including known risks and contraindications.

• The irrigation pump is designed for use only with the DiamondTemp irrigation tubing set. Fluid extension lines should not be used with the irrigation pump. Use of an inappropriate tubing set could cause conditions in the operation of the pump that may result in improper irrigation or air induction into the patient.

• The DiamondTemp tubing set is specially designed to minimize the noise that may be induced on electrograms by the triboelectric charge caused by the peristaltic motion of the irrigation pump head. The irrigation pump should not be used with any tubing other than the DiamondTemp tubing set.

• The irrigation pump is designed for use only with sterile heparinized normal saline solution. Specified flowrate accuracy may not be maintained when used with incompatible fluids or delivery devices.

• The irrigation pump is designed to terminate the flow of saline when certain operating conditions occur. Read all informational messages carefully. Some steps require user action before continuing the procedure.

• It is the responsibility of hospital personnel to monitor and track the total saline load delivered to the patient to prevent overinfusion of saline to the patient.

• To avoid the risk of electric shock, the irrigation pump must only be connected to a supply mains with protective earth ground.

• The irrigation pump should be placed on a hard, level surface and not be stacked on other equipment.

• Do not mount the irrigation pump on an IV pole.

• The air bubble detector is disabled during irrigation pump priming and purging functions. Do not prime or purge the catheter when it is inserted in the vasculature of the patient.

• Do not remove the irrigation tubing set from the irrigation pump while the tubing set is in line with a catheter that is inside the patient.

• The DiamondTemp ablation system has not been evaluated for safety and compatibility in the magnetic resonance (MR) environment. The safety of the DiamondTemp ablation system in the MR environment is unknown (such as any heating, migration, or image artifacts). Scanning a patient during the use of these devices may result in patient injury.

• Do not modify the irrigation pump or accessory components. Modifications may reduce system effectiveness and impact patient health.

• Carefully load the tubing set into the pump head. Do not attempt to remove the electrostatic discharge (ESD) pink sleeve positioned over the tubing set.

• The tubing set uses an ESD pink sleeve to reduce triboelectric-charge artifacts. The ESD pink sleeve is located on the outer surface between the retention clips. This section of the tubing set must be seated smoothly under the pump head rollers, with no bends, twists, or kinks.

• The irrigation pump should not be connected to other infusion systems.

• To avoid the risk of explosion, do not use the irrigation pump in the presence of flammable anesthetics or gases.

• To avoid the risk of electrical shock or fire, do not expose the irrigation pump to excessive moisture, especially when power is connected.

• To avoid the risk of exceeding the allowable touch current to the patient, do not simultaneously touch the patient and the accessible contacts of the pump-RFG communications connector. The connector is located on the irrigation pump’s rear panel.

• Moving parts such as the transparent pump head door, pump head clamps, and rotating pump head should be operated with care.

• Before use, inspect the irrigation pump and packaging to verify that no damage has occurred. Do not use damaged products.

• Do not immerse the irrigation pump in any liquid or expose the pump to steam autoclave or ethylene oxide (EtO) sterilization.

• Electromagnetic interference produced by the irrigation pump may adversely affect the performance of other equipment. Excessive EMI may cause the irrigation pump to enter a Safe State with a low flow rate. The pump 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 in) to any part of the DiamondTemp system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

• If for any reason the irrigation pump loses communication with the generator, or if the saline flow stops (0 mL/min), the generator displays an information message indicating that the condition should be corrected before any other steps are taken.

• During use of the irrigation pump, pay attention to all messages, error codes, warnings, indicators, and tones, and exercise caution as needed.

• There is no special handling, including no special storage or transport conditions, required for this device. Standard storage conditions are sufficient to safeguard the device. Store the device in the original packaging at room temperature in a dry place.

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 irrigation pump.

7 Unpacking the irrigation pump

Remove the power cord, Ethernet cable, and irrigation pump from the shipping container and inspect the irrigation pump. If the irrigation pump has been damaged during shipping, do not use and contact a Medtronic representative.

8 Setting up the irrigation pump

8.1 Electrical connections

The DiamondTemp irrigation pump is intended for use only with the DiamondTemp ablation system. The irrigation pump should be connected to the generator using the supplied Ethernet cable. Consult the generator user manual for additional details.

The irrigation pump operates using line power of 100 to 240 V, 50 to 60 Hz. The irrigation pump is not battery-powered and cannot be moved during use.

Caution: To avoid the risk of electric shock, the irrigation pump must be connected to a supply mains with protective earth ground.

8.2 Turning on the irrigation pump

Before operation, the irrigation pump must be placed on a stable surface. Complete the following steps to turn on the irrigation pump:

1. Ensure that the power cord is plugged into a power line of 100 to 240 V, 50 to 60 Hz. Connect the irrigation pump to a hospital-grade grounded power outlet only.

2. The power switch is located on the back panel of the irrigation pump near the power cord inlet. Turn on the switch at the rear of the irrigation pump. The Medtronic logo will appear on the front screen and the irrigation pump will perform a self-test.

3. Once the self-test has passed, a tone will sound, and the touch-screen display will indicate a flow rate of 0 mL/min.

4. The irrigation pump and generator must be used in communication mode. To establish this, plug the Ethernet cable into the inlet on the rear panel of the irrigation pump and connect the other end to the inlet on the rear panel of the generator.

5. Once communication is established between the two devices, a communication icon will be displayed on the upper portion of the irrigation pump touch-screen.

Figure 2. Rear Panel View of the Irrigation Pump

1 Power Switch 2 AC Power Cord Inlet 3 Equipotential Stud

4 Serial Port 5 Pump-Generator Communications Connector 6 USB Connection (maintenance)

8.3 Loading the tubing set in the irrigation pump

To load the tubing set in the irrigation pump, complete the following steps: Caution: The DiamondTemp irrigation pump is intended for use only with the DiamondTemp tubing set.

1. Connect the 3-way stopcock (provided with the tubing set) to the patient end of the tubing set.

Cautions:

• A new tubing set must be used for every procedure.

• Do not reuse the tubing set.

2. Insert the drip chamber end of the tubing set into the heparinized normal saline solution bag. Hang the saline bag near the irrigation pump and fill the drip chamber to approximately 2/3 full. Pass the patient end of the tubing set to the sterile field. While in the sterile field, open the stopcock and fill the tubing set with irrigation fluid at the patient end of the tubing set. Remove any trapped air and then close the 3-way stopcock. To ensure proper operation of the pump air bubble detectors, the outer surface of the tubing set must be dry.

3. Open the transparent pump head door of the irrigation pump by lifting up from the bottom (Figure 3) to release the tubing set guides and expose the tubing set path from the lower portion of the pump head.

Figure 3. Irrigation Pump with Pump Head Door Open

1 Transparent pump head door 2 Tubing guides

4. Note that the pump head rotates in a clockwise direction. Irrigation flow will enter the right-hand side of the pump and exit on the left hand side of the pump head. The indicator arrows that are molded onto the proximal and distal tubing set retention clips align with the direction of irrigation flow. Install the proximal tubing set retention clip (smaller of the two clips) into the tubing set retainer on the right-hand side of the pump head by inserting it into the tubing set retainer with the molded indicator arrow facing outward and in the direction of the pump flow path (Figure 4). Tactile feedback indicates when the tubing set retention clip is engaged

3 Tubing path around pump head 4 Tubing Set retainer

correctly into the retainer. Press the retention clip firmly into its respective slot. Confirm that the red warning light, visible through the clip, turns off after proper positioning.

5. Slide the pump head tubing set section under the pump head rollers into the tubing path, ensuring that the tubing set is grasped by each of the tubing set guides (Figure 4). The tubing set has special features to reduce triboelectric-charge artifacts. An ESD pink sleeve is placed over the tubing set, in between the retention clips.

Caution: Do not attempt to remove the pink ESD sleeve from the tubing set. Removing the sleeve may damage the tubing set or render it non-functional.

This section of the tubing set must be seated smoothly under the pump head rollers, with no bends, twists, or kinks. Place the tubing set snugly and smoothly over the two small metallic tubing set guides located to the right of the pump head rollers and over the one small metallic tubing set guide to the left of the pump head rollers.

Figure 4. Insertion of Proximal Pump Retention Clip and Pump Head Tubing Set Section

6. Gently stretch the tubing set and install the larger distal tubing set retention clip into the tubing set retainer on the left-hand side of the pump head in the same manner as described in step 4 (Figure 5). Press the retention clip firmly into its respective slot. Confirm that the red warning light, visible through the clip, turns off after proper positioning. Do not twist, bend, or kink the tubing set.

Figure 5. Insertion of Tubing Set Distal Pump Retention Clip

7. Ensure that all tubing set elements are correctly placed in the tubing set path and both tubing set retention clips are securely placed in the tubing set retainers. A red light will appear until clips are properly inserted.

8. Fully close the transparent pump head door of the irrigation pump (Figure 5). A message will appear at the bottom of the screen if the clips are not properly inserted. The message will disappear when the clips are properly inserted. Ensure that the irrigation pump touch-screen display does not show any messages. If the transparent pump head door of the irrigation pump is not closed properly, a “pump cover open” message will appear on the information bar at the bottom of the touch-screen display.

Note: A message will not appear if the transparent pump head door is in the raised position when the irrigation pump is turned on.

8.4 Preparing for irrigation

1. To prepare for irrigation, open the stopcock on the end of the tubing set, while continuing to maintain sterility on the patient end of the tubing set.

2. Press and hold the purge button (Figure 6) on the irrigation pump to verify tubing set integrity. If air is visible in the tubing set or if the pump displays an air bubble warning on the touch-screen display, press the purge button until the air is expelled through the open end of the tubing set. The air bubble warning should clear after successfully purging the tubing set.

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