Cool Point Operator Manual Aug 2014

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 pump is designed for 2-way communication and interface with SJM™ 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. Note: Accessories connected to the pump are considered part of the pump.

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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 2nd edition or 60601-1 3rd edition clause 16 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 2nd edition or 60601-1 3rd edition clause 16.

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4.0

PRECAUTIONS 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8

4.9 4.10 4.11 4.12 4.13

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. Dispose of used tubing set, residue, and waste according to normal institutional practice relating to potentially contaminated items. To avoid the risk of explosion, do not use the pump in the presence of flammable anesthetics. To avoid the risk of electrical shock and fire, do not expose the pump to excessive moisture. Use non-flammable agents for cleaning the pump surfaces; a low lint cloth/pad dampened with soap and water is recommended. 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. The pump has no user-serviceable components. The pump is calibrated by the manufacturer. Alteration of pump settings will cause improper operation and result in cancellation of the warranty. Moving parts such as the transparent door, pole clamp and rotating pump head, while designed for safe operation, should be operated with care. An irrigated catheter being used with Cool Point™ Irrigation pump must have a minimum burst pressure rating of 175 psi (11.9 atm). The Cool Point™ Irrigation Pump should only be used by or under the supervision of physician's trained in ablation procedures.

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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

Silence Alarm Key

High Flow 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.

BACK PANEL

Grounding Lug

Mounting Pole Power Switch

Power Cord Receptacle

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RS232 Foot Switch Connector

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6.0

Table of Alarms and Error Codes and Appropriate Action Error Code

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

Inspect the communication cable between Pump and the external device. Inspect the transparent pump head door is fully closed.

Inspect the pressure sensor receptacle is inserted securely into the plug in the pump front panel. If the fault occurs again, replace the Pressure Alarm Adapter Cable. If fault persists, contact your local St. Jude Medical Inc. sales or customer service representative.

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 Remove the air bubble from the tubing set. the Pump is running in Normal Flow Mode and Remove the catheter from the patient and use priming key the sensor detects a bubble. This fault will to purge air bubble from the system. not occur during priming or when the Pump Inspect the tubing set is properly routed through the bubble is stopped. detectors. Inspect for wet and dirt around the tubing in the bubble detectors. Bubble Detector Failure: This Fault occurs Turn power off and on again. if the periodic bubble detector self test If the fault occurs again, contact your local St. Jude Medical detects a failure. Inc. Sales or Customer Service representative. POST Failure: This Fault indicates the Turn power off and on again. device failed the Power-Up Self Test and is If the fault occurs again, contact your local St. Jude Medical not usable. Inc. Sales or Customer Service representative. Key stuck: This Fault indicates all keys Turn power off and press and release the entire front panel have not been released during POST either keys one at a time then turn power on. because the key is stuck or the user is holding If the fault occurs again, contact your local St. Jude Medical key(s) down. Inc. Sales or Customer Service representative. Speed Fault: This Fault indicates the Pump Inspect tubing is loaded properly into the pump. And is not moving within the tolerance of the turn power off and on again. commanded rate. If the fault occurs again, contact your local St. Jude Medical Inc. Sales or Customer Service representative.

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7.0

LABELING AND SYMBOLS NOTE: The symbols section contains all the symbols that may be used on product labels. Product is labeled as required. The position of the operator when viewing the label must be no greater than 0.6 meters per legibility requirements of IEC 60601-1 3rd Edition Clause 7.1.2. “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

Irrigation Pump Temperature Limitation

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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

Notified Body Mark

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. European Authorized Representative Finished Goods Number Package contains 1 item Pressure Alarm Adapter Cable

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8.0 TECHNICAL DATA Supply voltage 100-240VAC, 50/60 Hz Current rating 0.3A @120V or 70VA 0.5A, 250V Slow Blow Fuse Fuses rating Classification Class I per EN60601-1 International Standard. Type CF, IP22 Cool Point™ Irrigation Pump Complies with the following standards: EN60601-1:1990 EN60601-1-2:2001 UL60601-1:2003 IEC 60601-1:2005 3rd Edition IEC 60601-1:1988 2nd Edition, with Amendment No. 1 (1991) and No. 2 (1995) CAN/CSA 22.2 No. 601.1/M90) 1 to 5 ml/min (1 ml/min increments) Flow rate range (low range) Flow rate range (high range) 6 to 40 ml/min, (1 ml/min increments) 60 ml/min Prime flow rate Maximum operating back pressure Flow Rate Mode High Low

Center of Acceptable Triggering Range

Maximum pressure generated Flow rate accuracy Minimum detectable bubble size Dimensions • Height • Width • Depth • Weight • Power Cord

Tốc độ dòng + 40 psi (4 x Tốc độ dòng) + 25 psi

Tolerance +/-10 psi +/-10 psi

<140 psi (9.5 atm) ±10% for 1-30 ml/min ±15% for 31-40 ml/min 2 micro liters 21 cm (including the handle) 29 cm 18.5 cm (including the pump head) 3.75Kg 3m

Environmental specifications Transportation and Storage: - Temperature: -20°C to +40°C - Relative humidity: 10% to 90%, non-condensing - Atmospheric pressure: 700 to 1060 millibars (0.691 atm to 1.046 atm) Operating: - Temperature: 15°C to 40°C - Relative humidity: 20% to 90%, non-condensing - Atmospheric pressure: 700 to 1060 millibars (0.691 atm to 1.046 atm)

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Declaration – Electromagnetic Emissions The Cool Point™ Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Cool Point™ Pump should assure that it is used in such an environment. Emission Test

Compliance

Electromagnetic Environment-Guidance

RF emissions CISPR 11

Group 1

The Cool Point™ Pump uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Not applicable

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Not applicable

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The Cool Point™ 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.

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Declaration – Electromagnetic Immunity The Cool Point™ Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Cool Point™ Pump should assure that it is used in such an environment. IEC 60601 test level

Compliance level

Electrostatic discharge (ESD) EN61000-4-2 (IEC 1000-4-2)

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

Electrical fast transient/burst EN61000-4-4 (IEC 1000-4-4)

±2 kV for power supply lines ±1 kV for input/output lines

±2 kV

Surge EN61000-4-5 (IEC 1000-4-5)

±1 kV differential mode ±2 kV common mode

±1 kV

Immunity

Voltage dips, short interruptions and voltage variations on power supply input lines. IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

±1 kV

±2 kV

<5 % UT >95 % dip in UT for 0.5 cycle

>95 % dip in VNOM for 0.5 line cycle

40 % UT 60 % dip in UT for 5 cycles

60 % dip in VNOM for 5 line cycles

70 % UT 30 % dip in UT for 25 cycles

30 % dip in VNOM for 25 line cycles

<5 % UT >95 % dip in UT for 5 sec

>95 % of VNOM for 5 sec

3 A/m

3 A/m

Electromagnetic EnvironmentGuidance Floors should be wood, concrete or ceramic tile. If 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.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Cool Point™ Pump requires continued operation during power mains interruptions, it is recommended that the Cool Point™ Pump be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note UT is the a.c. mains voltage prior to application of the test level. Cool Point™ pump was tested at 100 and 240 VAC.

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Declaration-Electromagnetic Immunity The Cool Point™ Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Cool Point™ Pump should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic Environment-Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Cool Point™ Pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=[

3.5 ] P V1

d = [ 1.2 ] P Conducted RF EN61000-4-6 (IEC 1000-4-6)

d=[ 3 Vrms 150 kHz to 80 MHz

3 Vrms [ V1 = 3 ]

3 V/m 80 MHz to 2.5 GHz

3 V/m [ E1 = 3 ]

80 MHz to 800 MHz

d = [ 1.2 ] P d=[

Radiated RF EN61000-4-3 (IEC 1000-4-3)

3.5 ] P E1

7 ] P E1

800 MHz to 2.5 GHz

d = 2.3 P where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, 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. 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 Cool Point™ Pump is used exceeds the applicable RF compliance level above, the Cool Point™ Pump should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Cool Point™ Pump. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. ARTMT100109994 B (2014-09)

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Recommended separation distances between portable and mobile RF communications equipment and the Cool Point™ Pump The Cool Point™ Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Cool Point™ Pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Cool Point™ Pump as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter m Rated maximum output 80 MHz to 800 MHz 800 MHz to 2.5 GHz 150 kHz to 80 MHz power of transmitter 3.5 7 3.5 W ] P d=[ ] P d=[ ] P d=[ E1 E1 V1 0.01 .117 .117 .233 .10 .369 .369 .737 1 1.167 1.167 2.33 10 3.69 3.69 7.37 100 11.67 11.67 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated 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 manufacture. 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.

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