St. Jude Medical Cool Point Operator's Manual
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St. Jude Medical Cool Point Operator's Manual

St. Jude Medical Cool Point Operator's Manual

Irrigation pump
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Cool Point™ Irrigation Pump
Operator Manual
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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
Software "Revision 024"
Operator's Manual
Ръководство за експлоатация
Provozní příručka
Driftsvejledning
Bedienerhandbuch
Εγχειρίδιο χειριστή
Manual de funcionamiento
Kasutusjuhend
Käyttäjän käsikirja
Mode d'emploi
Kezelési útmutató
Manuale dell'operatore
작동 매뉴얼
Operatoriaus vadovas
Operatora rokasgrāmata
Gebruikershandleiding
Brukerhåndbok
Podręcznik użytkowania
Manual do Utilizador
Manual de utilizare
Руководство оператора
Návod na obsluhu
Uputstvo za upotrebu
Användarmanual
Operatör El Kitabı
操作手册
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
ARTMT100102832 A (2013-11)
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Summary of Contents for St. Jude Medical Cool Point

  • Page 1 Cool Point™ Irrigation Pump Operator Manual Software “Revision 024” English Operator's Manual Български Ръководство за експлоатация Česky Provozní příručka Dansk Driftsvejledning Deutsch Bedienerhandbuch Ελληνικά Εγχειρίδιο χειριστή Español Manual de funcionamiento Eesti Kasutusjuhend Suomi Käyttäjän käsikirja Français Mode d’emploi Magyar Kezelési útmutató...
  • Page 2 Cool Point™ Irrigation Pump Operator Manual Software “Revision 024” St. Jude Medical Irvine Biomedical, Inc. Coordination Center BVBA a St. Jude Medical Company The Corporate Village 2375 Morse Avenue Da Vincilaan 11 Box F1 Irvine, CA 1935 Zaventem 92614 USA...

  • Page 3: Table Of Contents

    Table of Contents CAUTION ......................3 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 ................

  • Page 4: Caution

    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.

  • Page 5: Pump Description

    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).

  • Page 6: Indications For Use

    Read directions prior to use. WARNINGS 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.

  • Page 7: Precautions

    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.

  • Page 8: Control Panel, Back Panel, And Indicators

    CONTROL PANEL, BACK PANEL, AND INDICATORS Foot Switch Total Volume LED Display Clear Error Key Low Flow Key Indicator Delivered 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.
  • Page 9 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 (“...
  • Page 10 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. •...

  • Page 11: Pump Setup

    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 Inc. Sales or Customer Service representative listed on the front cover of this Manual with any questions or concerns.

  • Page 12: Turning The Pump On

    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.
  • Page 13 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.
  • Page 14 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...
  • Page 15 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.

  • Page 16: Footswitch Operation (Optional)

    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). 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.

  • Page 17: Error Code

    If the fault occurs again, contact your local St. Jude Medical Inc. Sales or Customer Service is not plugged in and the Pump is not running and the user attempts to run representative.

  • Page 18: Labeling And Symbols

    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...
  • Page 19 Software Version Irrigation Pump 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 ARTMT100102832 A (2013-11) Page 18 of 785...

  • Page 20: Service, Maintenance, And Equipment Disposal

    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.

  • Page 21: Equipment Disposal

    10.5 Equipment Disposal Note: The IBI Cool Point™ Irrigation Pump contains electronic circuit assemblies. At the end of the useful life of the equipment, it should be disposed of in accordance to any applicable national standards or institution policy related to obsolete electronic equipment.

  • Page 22: Technical Data

    0.3A @120V or 70VA Fuses rating 0.5A, 250V Slow Blow Fuse 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.

  • Page 23: Accessories

    12.0 ACCESSORIES Cool Point™ Irrigation Pump Accessories Item# Catalog # Description 85784 Cool Point™ Irrigation Pump 1710 85710 Grounding Cable (2.8m / 8ft) 1452 85452 Foot Switch with cover (2.8m / 8ft ) (Optional) 1779 85786 Communication Cable, DB15M/DB9M generator to Pump (6m / 20ft) 85785 Cool Point™...

  • Page 24: Limited Sjm Warranty And General Service Policies

    Upon our distributor or customer discovering a defect in one of our Cool Point™ Irrigation Pump Device, whether or not the discovery occurs during the Initial Warranty Period and whether or not the Cool Point™ Irrigation Pump Device is subject to this limited warranty or a Maintenance Service arrangement, our distributor or customer should promptly advise our customer service department of the scope and nature of the problem, the conditions under which the problem was noticed, and request a “Returned Goods Authorization”...

  • Page 25: Appendix. A (Power Cord Identification)

    APPENDIX. A (POWER CORD IDENTIFICATION) Power Cord Primary Country Second Volt Freq. Plug 1 IBI P/N Volt 510755 Argentina 510757 Australia 510752 Belgium 510756 Brazil 510756 Canada 510755 China, People’s Rep. of Continental Europe (European Union minus 510772 220 or 230 United Kingdom, Italy, Belgium, France, Spain) 510752...
  • Page 26 Power Cord Primary Country Second Volt Freq. Plug 1 IBI P/N Volt 510753 Japan 50/60 510772 Korea, South 510759 South Africa 510752 Spain 510756 Taiwan 510772 Turkey 510751 United Kingdom 510756 United States ARTMT100102832 A (2013-11) Page 25 of 785...

  • Page 27: Appendix. B (Emc Declarations)

    APPENDIX. B (EMC DECLARATIONS) 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.

  • Page 28: Compliance Level

    IEC 61000-4-8 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. ARTMT100102832 A (2013-11) Page 27 of 785...

  • Page 29: Immunity Test

    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™...
  • Page 30 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.

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