Cool Point Operator Manual sw rev 024 Sept 2019

Cool Point™ Irrigation Pump Operator Manual Software “Revision 024”

Irvine Biomedical, Inc. a St. Jude Medical Company 2375 Morse Avenue Irvine, CA 92614 USA +1 855 478 5833 +1 651 756 5833 sjm.com

St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium +32 2 774 68 11

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Table of Contents PREFACE...3 1.0 PUMP DESCRIPTION...4 2.0 INDICATIONS FOR USE ...5 3.0 WARNINGS...5 4.0 PRECAUTIONS...6 5.0 CONTROL PANEL, BACK PANEL, AND INDICATORS...7 6.0 PUMP SETUP... 10 7.0 FOOTSWITCH OPERATION (OPTIONAL)... 15 8.0 ALARMS/ERROR CODES... 15 9.0 LABELING AND SYMBOLS... 17 10.0 SERVICE, MAINTENANCE, AND EQUIPMENT DISPOSAL... 19 11.0 TECHNICAL DATA... 21 12.0 ACCESSORIES... 22 13.0 LIMITED SJM WARRANTY AND GENERAL SERVICE POLICIES... 23 APPENDIX. A (POWER CORD IDENTIFICATION)... 24 APPENDIX. B (EMC DECLARATIONS)... 26

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DO NOT attempt to operate the Cool Point™ irrigation pump before thoroughly reading this Operator’s Manual. Operating instructions should be read, understood, and followed carefully. For future reference, keep this manual in a convenient, readily accessible place.

PREFACE The use of all components and accessories of the Cool Point™ irrigation pump is described in this manual. This manual provides a description of the pump, its controls and displays, and a sequence for its operation. Other important information has also been supplied for the user’s convenience.

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1.0

PUMP DESCRIPTION 1.1 1.2 1.3 1.4 1.5 1.6 1.7

The Cool Point™ irrigation pump is a peristaltic pump designed for the delivery of irrigation solution when used in conjunction with the Cool Point™ tubing set. The pump has a dual rate feature for one-touch irrigation rate change between a low flow rate (1-5 ml/min) and a high flow rate (6-40 ml/min). The front panel includes a large LED display, which indicates the flow rate selected and total flow delivered after a procedure. The flow rate during high flow and low flow delivery is user selectable and/or adjustable. A transparent door protects the rotating head, while allowing visibility of the entire tubing set during pump operation. Bubble detectors are employed for added safety in preventing air infusion. A removable side-mounted pole clamp is included for mounting the pump to a standard IV pole or a hospital Bed rail. The IBI Pump is designed for 2-way communication and interface with St. Jude Medical™ ablation generators (herein referenced as "external device"). The pump has built-in safety features, which include a self-test at power up and a cessation of pumping for various alarm states both audible and visual. Delivery of irrigation solution stops when the pump detects air in the tubing set, the door is opened, an occlusion is detected or the pressure sensor is disconnected. The pump automatically will switch to low flow rate when the pump senses a loss of communication with the external device (only when the pump is used with the external device and not when the pump is used in its manual mode).

Figure A 1.8

The irrigation pump and accessories cited in this manual are suitable for use within the patient environment.

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2.0

INDICATIONS FOR USE The Cool Point™ irrigation pump is a peristaltic pump that is intended for use in administration of irrigation solution into the patient through an open irrigated ablation catheter. The Cool Point irrigation pump is intended for use only with the Cool Point™ tubing set. 2.1 CAUTION - Read directions prior to use.

3.0

WARNINGS 3.1 3.2

3.3 3.4 3.5

3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13 3.14

The Cool Point™ irrigation pump is designed for use with only the Cool Point™ tubing set. Use of other types of tubing may cause improper operation of the pump and can result in improper irrigation. Hospital personnel are responsible for verifying that the irrigation solution is correct and that the compatibility of the devices are to be used in conjunction with the pump. Flow can be verified visually by noting the drip rate in the drip chamber. Hospital personnel are responsible for verifying and monitoring the flow rate delivered to prevent under-delivery of irrigation solution. Hospital personnel are also responsible for periodically monitoring the accuracy of the flow rate during the procedure. The pump is designed to stop the flow of irrigation when an alarm is activated. All alarms must be attended immediately to continue irrigation. Loss of communication with the external device will not stop the flow of irrigation solution but will automatically switch from a high flow to low flow rate. Hospital personnel are responsible for monitoring the total saline load delivered to the patient to prevent over-infusion of irrigation solution. Hospital personnel are responsible for verifying the proper performance of the pump and the compatibility of the irrigation solution and irrigation devices used as part of the overall irrigation management. The Cool Point irrigation pump and Cool Point tubing set are designed for use with irrigation solution. Specified flow rate accuracy may not be maintained when used with incompatible fluids or delivery devices. During use, monitor tubing set for visible bubbles and stop pump if air bubbles are observed. The pump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, observe the pump to verify normal operation in the configuration in which it will be used. Do not place any additional item on top of the pump when mounted to IV pole. Intentional misuse of the pump will cause serious injuries to the operator and/or patient. Do not prime the catheter while it is in the patient. Proper care should be taken in disposing of the used tubing set. Position connecting cables and tubing to avoid contact with the patient and contact with other cables. Position device such that the power supply cord connection is easily accessible as a means of disconnecting power from the device. Position the pump so that the front panel is easily accessible. When connecting the pump or its components to any other device or system, verify proper operation before clinical use. Accessory equipment connected to the pump interface(s) must be certified according to the respective IEC standards, i.e. IEC 60950 for data processing equipment or IEC 60601-1 for electro medical equipment. All combinations of equipment must be in compliance with IEC 60601-1 Medical Electrical (ME) systems requirements. Anyone connecting additional equipment to the signal input or output connectors configures a medical system, and therefore, is responsible that the system complies with the requirements of the system standard IEC 60601-1 ME systems requirements.

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4.0

PRECAUTIONS Follow the system setup to achieve optimal use. The pump should not be ported together with other infusion systems, including gravity fed IV infusion systems. To avoid the possibility of biological contamination, and to ensure proper performance, do not reuse or re-sterilize the Cool Point™ tubing set. The tubing set is intended for single use only. 4.4 Dispose of used tubing set, residue, and waste according to normal institutional practice relating to potentially contaminated items. 4.5 To avoid the risk of explosion, do not use the pump in the presence of flammable anesthetics. 4.6 To avoid the risk of electrical shock and fire, do not expose the pump to excessive moisture. 4.7 Use non-flammable agents for cleaning the pump surfaces; a low lint cloth/pad dampened with soap and water is recommended. 4.8 This equipment has been tested and found to comply with the limits for medical devices in IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. 4.8.1 External high-energy radio frequency interference (RFI) and electromagnetic radiation (EMR) can cause false alarms or compromised performance in electrical equipment such as the pump. In addition, electrical equipment such as the pump can occasionally induce artifacts on ECG monitoring systems that are not operating under optimal conditions. Although the pump has been designed to prevent such interference, safe operation should be verified prior to patient use when used in conjunction with RF electro-surgical equipment, electromagnetic navigation systems and ECG monitoring equipment. If interference occurs, reposition the pump. 4.8.2 This equipment generates and may radiate radio frequency energy. If not installed and used in accordance with the instructions, this equipment may cause harmful interference to other devices in the vicinity. Even though this equipment has been tested and found to comply with the limits for medical devices, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: 4.8.2.1 Reorient or relocate the receiving device. 4.8.2.2 Increase the separation between the equipment. 4.8.2.3 Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. 4.8.2.4 Consult the manufacturer for help. 4.9 The pump has no user-serviceable components. 4.10 The pump is calibrated by the manufacturer. Alteration of pump settings will cause improper operation and result in cancellation of the warranty. 4.11 Moving parts such as the transparent door, pole clamp and rotating pump head, while designed for safe operation, should be operated with care. 4.12 An irrigated catheter being used with Cool Point™ irrigation pump must have a minimum burst pressure rating of 175 psi (11.9 atm). 4.13 The Cool Point irrigation pump should only be used by or under the supervision of physician's trained in ablation procedures. 4.1 4.2 4.3

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5.0

CONTROL PANEL, BACK PANEL, AND INDICATORS Total Volume Delivered

LED Display

Clear Error Key

Low Flow Key

Foot Switch Indicator Automatic Control Indicator High Flow Key

Silence Alarm Key Flow Rate Change Key

Stop Key

Priming Key Front Panel

FRONT PANEL The control panel, located on the front of the pump, is used to set and display the flow rate, and to control pump operation. 5.1

Stop key: Press to stop rotation of the pump head. The pump will beep once to indicate that flow has stopped. Press the Low Flow or High Flow key to restart the flow. • The stop key indicator will be off to indicate the pump is delivering irrigation solution. • The stop key indicator will be yellow to indicate the pump is stopped and ready for use. • The stop key indicator will be red to indicate the pump is stopped and an error needs to be cleared. • The stop beep is longer than the low flow rate beep.

Warning: Pressing the Stop key during procedure will stop the delivery of the irrigation solution. 5.2

Prime key: Press the Prime key twice in less than 2 seconds to flush the tubing set. A flow of 60 ml/min will stay for 30 seconds and a periodic beep will be audible during the priming and the green LED will be on. • Priming can be stopped sooner if the stop key is pressed. • Air bubble detection in tubing is disabled during this process.

5.3 Low Flow key: Press to initiate flow at the preset low flow rate. The pump beeps once when the low flow rate begins. The default low flow rate is 2 ml/min. Low flow rate can be set from 1 ml/minute to 5 ml/minute. Use associated rate setting change keys (“ ” or “ ”) to set the low flow rate. • The low flow rate beep is shorter than the stop beep.

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High Flow key: Press to initiate flow at the preset high flow rate. The pump beeps twice when the high flow rate begins. The default high flow rate is 17 ml/min. High flow rate can be set from 6 ml/minute to 40 ml/minute. Use associated rate setting change keys (“ ” or “ ”) to set the low flow rate. Note: For irrigation solution flow to begin when the High or Low Flow keys are pressed these conditions must be fulfilled: • The pump is not in an error state. • The door must be closed. • The Pressure Sensor must be plugged in and an occlusion is not detected. • The Bubble Sensors do not detect a bubble. Note: The High Flow and Low Flow keys will be disabled and ignored when the pump has established serial communications with the external device and the Pump is in Normal Flow Mode. Note: The High Flow and Low Flow keys are disabled if the Footswitch is connected and the Footswitch is pressed. 5.4

Rate Setting Change keys: There are two sets of Increase/Decrease keys, one set under the Low Flow key, the other under the High Flow key. Press the “ ” or “ ” key to increase or decrease the respective flow rate by 1 ml/min. Pressing and holding the “ ” or “ ” key adjusts the flow rate more rapidly. When adjusting the high or low flow rate, the LED display temporarily indicates the new setting for the associated flow rate, regardless of the current flow rate of the pump. The new setting remains in effect until it is changed, or the pump is turned off. Note: The Rate Settings keys are not allowed during Priming or while the pump is in an alarm state. 5.5

Total Volume delivered key: This key allows the user to view the amount of irrigation solution pumped since power on or resetting of the total volume. Total volume can be reset by the user. This gives the capability to capture the volume of irrigation solution irrigated into the patient after priming is completed. • Press to display total volume dispensed. The total volume will remain displayed for 3 seconds after the key is released. • To reset the total volume dispensed to zero press and hold the total volume key for 5 seconds. The the value will display “0000” when the volume has been reset. • While the pump is used monitor the total volume delivered by pressing and releasing the total volume delivered Key. Notes: • Monitor the display during the operation for power failure or error alarm. • The Total Volume delivered key is not allowed during Priming. 5.6

5.7 Alarm Silence key: When errors occur during operation, the pump shows the error code on the display sounds the error tone and lights the Alarm Silence Indicator. Pressing the Alarm Silence key will silence the alarm for two minutes after which if the Alarm Clear key has not been pressed the alarm error tone will sound and the user will have to press the Alarm Silence key again before pressing the Alarm Clear key to clear the error. 5.8 Alarm Clear key: This key indictor will be on when Silence Alarm Key is pressed. Once an error has been corrected, press Alarm Clear key to clear the error from the display. The pump returns to normal operating mode. Notes: • Discontinue using the pump if keys do not respond and the pump has not established serial communication with the external device. • Exception: The High/Low flow keys will be disabled when the footswitch is connected and pressed.

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LED Display: The LED display indicates the flow rate, total volume dispensed information or error code. • When an error is detected the error code is displayed until that error has been cleared. Upon clearing the error the current flow rate of the pump is displayed. • When adjusting the flow rate, the new setting for the associated flow rate is briefly displayed, regardless of the current flow rate of the pump. 5.10 Automatic Communications Control Indicator: The communications indicator is green when the External device establishes and maintains serial communications with the pump. 5.11 Footswitch Indicator: Footswitch indicator is green when pump is under the footswitch control. 5.9

BACK PANEL

Grounding Lug

Mounting Pole Power Switch

Power Cord Receptacle

RS232 Foot Switch Connector

5.12 Main Power Switch: Main AC mechanical power switch to turn power ON by depressing the rocker switch to the “I” position and OFF by depressing the rocker switch to the “O” position. 5.13 Power Cord Receptacle: Provided to attach the power cord to the pump (refer to Appendix. A for the Power Cord selection). 5.14 RS232 connector: The pump is capable of accepting and executing from an external device High and Low Flow Rate irrigation solution delivery control commands via RS232 connection with the external device. Refer to the external device for more information. Communications indicator is green when the external device has established and maintains serial communication with the pump. RS232 connector is only meant to be used with an approved SJM™ ablation generator via the communication cable. See ablation generator IFU for more information and system compatibility. 5.15 Mounting Pole: This pole is used in junction with the C-Clamp to mount the pump to a standard IV pole or Pole or a Hospital Bed Rail. (Refer to section 6.2) 5.16 Grounding Lug: Provided for connecting the pump’s ground to the EP monitoring device’s ground. 5.17 Foot Switch Connector: It is provided to connect to the IBI foot switch (85452) to initiate the high flow rate.

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6.0

PUMP SETUP 6.1

UNPACKING AND GENERAL INSPECTION 6.1.1 Thoroughly inspect the outside of all shipping containers for indications of damage. Contact the shipping firm as necessary to resolve shipping damage. 6.1.2 Carefully remove components from shipping cartons and packaging material and inspect all components carefully to make certain they have not been damaged in shipment. Contact your local St. Jude Medical LLC Sales or Customer Service representative listed on the front cover of this Manual with any questions or concerns. 6.1.3 The following items are required for use and are included in the shipping carton: 6.1.3.1  Cool Point™ irrigation pump 6.1.3.2  Cool Point irrigation pump operator manual 6.1.3.3 Power Cord in plastic bag 6.1.3.4 IV Pole Mounting C-Clamp 6.1.3.5 Communication Cable, Reorder # IBI-85786 6.1.4 The following additional items are needed for use and are available separately: 6.1.4.1  Cool Point™ tubing set 6.1.5 Remove the power cord from its plastic bag and attach to the AC Inlet Module on the back of the pump. When used outside the US, reference Appendix A for identification of appropriate power cord. 6.2 MOUNTING THE PUMP TO THE IV POLE 6.2.1 The pump can be mounted on a standard IV pole or horizontal Mounting rail by using removable C-Clamp. 6.2.2 Firmly clamp the C-Clamp onto the IV Pole or mounting rail near the patient. 6.2.3 Slide the mounting Pole into the C-Clamp. Mounting Pole

C-Clamp

IV Pole Figure.B 6.2.4

Attach any desired optional equipment.

NOTE: • It is recommended that a 6-legged hospital grade IV pole, able to support the weight of the pump, be used. • 1 liter irrigation solution bag attached to the side opposite the pump at a height no more than 7 ft. (2.1 m) above the ground (to IV pole hook). • Pump’s pole clamp located no more than 5 ft. (1.5 m) above the ground.

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6.3 TURNING THE PUMP ON 6.3.1 Connect power cord to grounded outlet with the appropriate voltage. 6.3.2 Turn on the power switch located on the back panel near the power cord inlet. Once turned on, the pump performs a self-test and you will hear an audible beeping tone, all the light indicators are on and the software revision will be displayed. Once the self-test has passed, the display will indicate a flow rate of 00 ml/m. 6.4 LOADING THE TUBING SET INTO THE PUMP NOTE: Use only the Cool Point™ tubing set. To avoid contamination remove the Cool Point tubing set from its packaging using standard safe hospital practice and inspect tubing set integrity prior to the setup. 6.4.1 Obtain the irrigation solution container and prepare per hospital standard then connect the Cool Point tubing set to the irrigation solution container using standard safe hospital practices (Use Aseptic Technique). A new tubing set must be used for every procedure. Warning: Do not reuse the tubing set. 6.4.2 Make sure 3-way stopcock is closed to the catheter prior to use. 6.4.3 Hang and spike the irrigation solution container near the pump. Gently squeeze and release drip chamber. NOTE: Vent cap should remain in a closed position unless solution is in a solid stopper glass bottle. 6.4.4 Purge air, open the 3-way stopcock, and fill the tubing set with the irrigation solution. Remove any trapped air and then close the stopcock. 6.4.5 Open the transparent Pump Head door completely as seen in Figure C. Pump Door

Figure C 6.4.6 Route the tubing to the first bubble sensor by gently stretching the tube through the bubble sensor as shown in Figure D. It is not necessary to pull the tubing tight from the pressure sensor. Lock the guide key into position. NOTE: To prevent false bubble detection, keep liquid from the outside of the tubing at the interface with the air bubble detectors.

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Bubble Detector

Figure D 6.4.7 Route the tubing through the pump taking care to make sure the tubing is placed in the hooks on either side of the pump as shown in Figure E. Tubing should be routed against the pump rollers and should not be pulled tight or there be excess slack in the tubing, see Figure F. Hooks

Figure E 6.4.8 Complete the tube routing by gently stretching the section through the second bubble sensor as shown in Figure F. Lock the guide key into position. Bubble Detector

Figure F

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6.4.9  Plug the pressure sensor into the front panel as shown in Figure G.

Pressure Sensor Plug

Figure G 6.4.10 Close the transparent Pump Head door. The completely routed tubing set looks as shown in Figure H.

Tubing Set Guide Keys

Figure H 6.4.11 The pump is capable of accepting and executing from an external device High and Low Flow Rate irrigation solution delivery control commands via the RS232 connection. Refer to St. Jude Medical™ ablation generator IFU for more information. The Communications indicator is green when the external device has established communication and has maintained serial communication with the pump.

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6.5 PRIMING THE TUBING SET/CATHETER WARNING: DO NOT PRIME WHILE THE CATHETER IS INSIDE THE PATIENT. NOTE: PRIMING WILL BE DONE BEFORE INSERTION OF EACH NEW CATHETER. Priming will only occur if all the following conditions are fulfilled: • The pump is not in an error state (alarm must be cleared). • The pump is stopped. • The Door is closed. • The Pressure Sensor is connected. • The Prime Key is pressed twice in less than 2 seconds. 6.5.1 Remove the Catheter from its packaging using standard practice and inspect catheter integrity. 6.5.2 Prepare the catheter per catheter’s IFU. 6.5.3 The catheter may now be connected to the male end of the tubing set. 6.5.4 Open 3-way stopcock on the end of the tubing set. 6.5.5 Press the PRIME key twice in less than 2 seconds to flush the tubing set. A flow rate of 60 ml/min will stay for 30 seconds and a periodic beep will be audible. The Priming Key LED will turn green during priming. 6.5.6 Visually inspect flow through the tubing set. Ensure that there is NO leak in the tubing set or catheter and that NO air bubbles are present while irrigation solution is being delivered from the catheter. 6.5.7 During the prime mode, visually inspect flow through the tubing set and ensure that the solution is flowing through tubing set. 6.5.8 Confirm acceptable irrigation solution temperature before use. 6.5.9 Press low flow key to start flow at the default value of 2 ml/min. 6.5.10 Occlusion Alarm Verification 6.5.11 To verify the occlusion alarm working properly, stop the flow by closing 3-way stopcock: • Pump head stops. • Repeating alarm tone sounds. • Numeric display shows “OCCL”. • Alarm silence indicator is lit red. • Stop indicator is lit red. 6.5.12 Press the alarm silence key and then press the clear key. 6.5.13 If the occlusion alarm is not detected, replace the Cool Point™ tubing set and then repeat the section 6.4.1 -6.5.12. 6.5.14 Press the low flow key to start flow at the preset or default value of 2 ml/min. 6.5.15 The pump is now ready for use. 6.5.16 Attach the tubing set’s depot clip to the sterile sheet to prevent the tubing set from wrapping around and constricting the tissue.

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7.0 FOOTSWITCH OPERATION (OPTIONAL) Attach the Footswitch (IBI P/N: 85452 ) to the Cool Point™ irrigation pump in the socket at the back of the pump (refer to the pump’s back panel picture). 7.2 The Footswitch can be used to switch the flow rate to High Flow from the Low Flow rate by pressing and holding the footswitch, an audible sound of two beeps when changing to the High Flow Rate irrigation solution delivery and the footswitch indicator will then turn green. 7.3 Releasing the footswitch will switch the flow rate from High Flow to Low Flow with an audible sound of one beep and turn off the footswitch indicator. The footswitch indication is green under the following conditions. • The External device has not established serial communications.(Communications indicator is off) • The pump is either in Low Flow rate or High Flow rate mode. (Cannot be stopped or priming) • The pump is not in an alarm state. • The footswitch was pressed after the Low Flow rate or High Flow rate was started. Notes: • Discontinue using the pump if the footswitch does not respond and the pump has not established serial communication with the external device. Exception: The High/Low flow keys will be disabled when the footswitch is connected and pressed. • Pressing the footswitch while stopped or priming and then pressing the Low or High Flow rate key will not switch the pump to High Flow. 7.1

The Optional Footswitch (IBI P/N: 85452) 8.0

ALARMS/ERROR CODES 8.1

Errors and Information Displays 8.1.1 There are two categories of errors: Faults and the Communication Lost error with the external device. 8.1.2 Initially when errors occur during operation, the pump shows the error code on the display, sounds the error tone and lights the Alarm Silence Indicator. 8.1.3 If the error is a Fault, the pump head stops. If the error is the Communication Lost Error and the pump is running at the High Flow Rate, the pump changes to the Low Flow Rate. 8.1.4 A fault error takes precedence over the Communication Lost Error and is handled before or during a Communication Loss Error.

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8.2

Table of Alarms and Error Codes, and the appropriate action

Error Code

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Alarm/Error

Action

Communication lost: The pump has lost serial communications with the external device. This is the only error which is not a Fault.

Inspect the communication cable between Pump and the external device.

Door Open: This Fault occurs when the Pump is running and the door is opened or the Pump is not running and the user attempts to run the Pump by pressing the Prime key, the Low Flow Rate key or the High Flow Rate key.

Inspect the transparent pump head door is fully closed.

Pressure Sensor Not Connected: This Fault occurs when the Pump is running and the pressure sensor has been unplugged or the pressure sensor is not plugged in and the Pump is not running and the user attempts to run the Pump by pressing the Prime key, the Low Flow Rate key or the High Flow Rate key. This indicates the tubing set may not have been installed.

Inspect the pressure sensor receptacle is inserted securely into the plug in the pump front panel. If the fault occurs again, contact your local St. Jude Medical LLC Sales or Customer Service representative.

Occlusion Detected: This Fault occurs when the Pump is running and over pressure is detected.

Inspect the downstream tubing kink and correct it. Inspect the 3-way stopcock is in open position. Inspect for blockage. Inspect the attached catheter for kink and follow the catheter’s IFU.

Bubble Detected: This Fault occurs when the Pump is running in Normal Flow Mode and the sensor detects a bubble. This fault will not occur during priming or when the Pump is stopped.

Remove the air bubble from the tubing set. Remove the Catheter from the patient and use priming key to purge air bubble from the system. Inspect the tubing set is properly routed through the Bubble detectors. Inspect for wet and dirt around the tubing in the bubble detectors.

Bubble Detector Failure: This Fault occurs if the periodic bubble detector self test detects a failure.

Turn power off and on again. If the fault occurs again, contact your local St. Jude Medical LLC Sales or Customer Service representative.

POST Failure: This Fault indicates the device failed the Power-Up Self Test and is not usable.

Turn power off and on again. If the fault occurs again, contact your local St. Jude Medical LLC Sales or Customer Service representative.

Key stuck: This Fault indicates all keys have not been released during POST either because the key is stuck or the user is holding key(s) down.

Turn power off and press and release the entire front panel keys one at a time then turn power on. If the fault occurs again, contact your local St. Jude Medical LLC Sales or Customer Service representative.

Speed Fault: This Fault indicates the Pump is not moving within the tolerance of the commanded rate.

Inspect tubing is loaded properly into the pump. See Section 5.3. Figure F, and turn power off and on again. If the fault occurs again, contact your local St. Jude Medical LLC Sales or Customer Service representative.

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9.0

LABELING AND SYMBOLS NOTE: The symbols section contains all the symbols that may be used on product labels. Product is labeled as required. “ON” (Power) “OFF” (Power) Low Flow Rate High Flow Rate Prime Alarm Silence Increase Decrease Defibrillation-proof type CF applied part Stop (of action) Caution: Equipotentiality Foot switch Automatic Control Total Volume Delivered Alarm Clear Key Serial Interface

Dispose of hardware in accordance with local law

Software Version Compliance with the Ordinance 54 of 2016 of INMETRO Irrigation Pump

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Temperature Limitation

Relative Humidity

Package contains 1 item Plus accessories

Catalogue Number

Serial Number

Do not use if package is damaged

Non-sterile

Lot number

Manufacturer

Consult instructions for use

Read instructions for use Date of manufacture Manufacturing Facility Fragile; handle with care Keep dry; keep away from rain Safety Agency Mark Authorized Representative in the European Community Confirmité Européenne (European Conformity). Affixed in accordance with European Council Directive 93/42/EEC and 2011/65/EU. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive. ARTMT600040967 C (2019-09)

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10.0 SERVICE, MAINTENANCE, AND EQUIPMENT DISPOSAL The pump requires no routine service or maintenance. If the pump fails to operate when plugged into a proper AC power receptacle and the POWER Switch is turned “ON”, check the fuse. If a second failure occurs, notify Irvine Biomedical for service. Clean and repackage the irrigation pump appropriately and return it for repair, servicing and/or modification to Irvine Biomedical authorized service center. If the pump is not under warranty an appropriate handling and repair charge will be established after receipt and examination of controller. The pump contains no user-serviceable units; disassembly and attempted repair by unqualified personnel may create a hazardous condition and will void the warranty. NOTE: DO NOT REMOVE THE COVER OF THE PUMP. REMOVING THE COVER MAY RESULT IN PERSONAL INJURY AND/OR DAMAGE TO THE PUMP. 10.1 Fuse Replacement 10.1.1 Turn the pump off and remove the power cord. 10.1.2 Using a small flat screwdriver, open the fuse cover on the AC Power Inlet Module on the back of the pump as shown in Figure 1.

Figure 1 10.1.3 There are 2 fuse holders, upper and lower; remove the fuse holders as shown in Figure 2 and 3.

Figure 2

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Figure 3

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