Medivance BD Arctic Sun 6000 Operator's Manual
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Medivance BD Arctic Sun 6000 Operator's Manual

Stat temperature management system
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Summary of Contents for Medivance BD Arctic Sun 6000

  • Page 1 14868...
  • Page 2 Operator’s Manual tube...

  • Page 3: Table Of Contents

    Operator’s Manual Patient Not Controlling ....34 TABLE OF CONTENTS No Patient Temperature Display 35 SCREEN ........... 35 SYMBOLS ..........4 Screen Locked ......35 WARNINGS AND CAUTIONS Wireless Connection Lost ... 35 DEFINITION ............ 8 IX. CLEANING AND DISINFECTION ..36 III.

  • Page 4: Symbols

    Operator’s Manual SYMBOLS The Arctic Sun™ Temperature Management System and its packaging bear the following symbols: Symbol Standard Reference Standard Title Symbol Title Explanatory Text ISO 15223-1 Medical Devices- Manufacturer Indicates the medical Reference no. 5.1.1 Symbols to be used with device manufacturer.
  • Page 5 English The current Operator’s Manual can be found at www.medivance.com/manuals Symbol Standard Reference Standard Title Symbol Title Explanatory Text IEC TR 60878 Graphical Symbols for Refer to instruction To signify that the Reference ISO Electrical Equipment in manual/booklet instruction 7010-M002...
  • Page 6 Operator’s Manual Symbol Standard Reference Standard Title Symbol Title Explanatory Text IEC TR 60878 Graphical Symbols for Equipotentiality To identify the terminals Reference no. 5021 Electrical Equipment in which, when connected Medical Practice together, bring the various parts of an equipment or of a system to the same potential, not necessarily being the...
  • Page 7 English The current Operator’s Manual can be found at www.medivance.com/manuals Symbol Standard Reference Standard Title Symbol Title Explanatory Text AAMI ES 60601-1 Medical electrical ETL Monogram Per ETL Intertek, models IEC 60601-1-8 equipment-Part 1: of the ARCTIC SUN™ IEC 60601-10...

  • Page 8: Warnings And Cautions Definition

    Operator’s Manual Symbol Standard Reference Standard Title Symbol Title Explanatory Text To identify the number to call for urgent clinical support. The number shall be placed adjacent to the symbol. Plug Type WARNINGS AND CAUTIONS DEFINITION WARNINGS and CAUTIONS throughout the manual should be carefully reviewed before and during use of the device. Informs the reader about a situation which, if not avoided, could result in death or serious injury.

  • Page 9: Safety Precautions

    English The current Operator’s Manual can be found at www.medivance.com/manuals small patients (≤30 kg) it is recommended to use the following settings: Water Temperature High Limit ≤40°C III. SAFETY PRECAUTIONS (104°F); Water Temperature Low Limit ≥10°C (50°F); Control Strategy = 2. It is recommended to use the Patient...

  • Page 10: Complications

    Operator’s Manual • CAUTIONS (Continued) • Do not allow circulating water to contaminate a sterile field • Do not place ArcticGel™ pads over an electrosurgical when patient lines are disconnected. grounding pad. The combination of heat sources may • The water content of the hydrogel affects the pad’s result in thermal injury.

  • Page 11: Introduction

    English The current Operator’s Manual can be found at www.medivance.com/manuals Parameter Specification INTRODUCTION Normothermia: Control Patient, Therapy Modes Rewarming Hypothermia: Cooling, Rewarming TECHNICAL DESCRIPTION Heater Maximum Power 814 Watts Circulating Fluid Sterile Water with Cleaning Solution The Arctic Sun™ Temperature Management System is a Average Reservoir Capacity 3.5 liters...

  • Page 12: System Components

    Temp 1 Power circuit. For information regarding safe handling, please refer to Switch Patient http://www.medivance.com/manuals for the Cleaning Solution SDS. Temp 2 Port Patient Temperature Input Cables and Probes Patient Patient temperature control with the Arctic Sun™ Temperature...
  • Page 13 English The current Operator’s Manual can be found at www.medivance.com/manuals site for increased patient safety when patient temperature is not continuously monitored by a second device. NOTE: Patient temperature is not controlled from the Temp In 2 connector. It is for patient temperature monitoring only.

  • Page 14: Setup Procedure

    Operator’s Manual SETUP PROCEDURE FUNCTIONAL VERIFICATION UNPACK Certificates of Conformance for calibration, performance, and electrical safety tests are included with the shipment of each Unpack the Arctic Sun™ Temperature Management Arctic Sun™ Temperature Management System. To verify the System Control Module and accessories. system will heat and cool properly, perform the following Allow the Control Module to remain upright for at least two functional verification procedure after initial setup and...

  • Page 15: Operation Guide

    English The current Operator’s Manual can be found at www.medivance.com/manuals press the button next to Normothermia to display the OPERATION GUIDE Normothermia therapy screen. Pressing the Normothermia button will initiate a New Patient THERAPY PREPARATION therapy and will reset the Normothermia therapy screen to the saved system default settings.

  • Page 16: Therapy Screens

    Operator’s Manual THERAPY SCREENS The following information is displayed and functions are available from the Normothermia and Hypothermia therapy screen. Therapy Selection (or Screen Lock) System Access Notification Temperature Units (if enabled) Patient Status Patient Temperature Patient Temperature 2 (if enabled) System Status Water Temperature Flow Rate...
  • Page 17 English The current Operator’s Manual can be found at www.medivance.com/manuals THERAPY SCREENS (Continued) The following information is displayed and functions are available from the Normothermia and Hypothermia therapy screen. Therapy Selection (or Screen Lock) System Access Notification Temperature Units (if enabled)
  • Page 18 Operator’s Manual THERAPY SCREENS (Continued) Notification Notifications are active when attention to the system is Therapy Selection required (e.g. preventative maintenance). If the therapy has not started or is not currently running, pressing the therapy selection button ( ) will return the user to the Therapy Selection screen.
  • Page 19 English The current Operator’s Manual can be found at www.medivance.com/manuals H. Progress Bar • A progress bar displays on the bottom of the THERAPY SCREENS (Continued) temperature graph to signify the operating modes active throughout the therapy. • Patient Temperature 2 must be enabled in the •...
  • Page 20 Operator’s Manual THERAPY SCREENS (Continued) Upper limit 10. Monitor Mode Control Strategy The Monitor Mode feature delivers active therapy when Range: 33.5°C to 38.5°C 32.5°C to 38.5°C user-defined thresholds are crossed. This feature is useful 92.3°F to 101.3°F 90.5°F to 101.3°F for temperature surveillance of the patient.
  • Page 21 English The current Operator’s Manual can be found at www.medivance.com/manuals NOTE: If the Arctic Sun™ Temperature Management THERAPY SCREENS (Continued) System was previously in stop mode, or if the target temperature has been changed, the Arctic Sun Work to Cool Trend graph will be greyed, and the icon will display...
  • Page 22 Operator’s Manual Range: 0.01 to 0.50°C/hour THERAPY SCREENS (Continued) 0.02 to 0.90°F/hour Increments: 0.01 °C/hour (0.01-0.35°C/hour) Start or Stop 0.05°C/hour (0.35-0.50°C/hour) Start Therapy 0.02°F/hour (0.02-0.58°F/hour) From the Normothermia therapy screen or the 0.09°F/hour (0.59-0.90°F/hour) Hypothermia therapy screen, press the Start button to start therapy and begin the flow of water to the ArcticGel™...

  • Page 23: Initiate Therapy

    English The current Operator’s Manual can be found at www.medivance.com/manuals Greater than 2.0 C (3.6 F) change per hour Initiate Hypothermia (Cooling and Rewarming) THERAPY SCREENS (Continued) Hypothermia therapy is initiated and managed, and patient temperature is automatically controlled to a set target 18.

  • Page 24: Interrupt Therapy For Patient Transport

    Operator’s Manual desired. Doing so will delete all previous patient therapy data and settings. INITIATE THERAPY (Continued) Initiate Patient Rewarming 14) The Normothermia therapy or Hypothermia therapy • Upon completion of the cooling phase, there are two screen from the therapy session will appear, and the options for initiation of patient rewarming, either therapy settings will be active.

  • Page 25: Therapy Settings

    English The current Operator’s Manual can be found at www.medivance.com/manuals Cooling Begins THERAPY SETTINGS Use the Cooling Begins parameter to set the event that triggers when the cooling duration timer starts. The options are to start the timer immediately after pressing...
  • Page 26 Operator’s Manual THERAPY SETTINGS (Continued) High Water Limit Use the High Water Limit to set the maximum water Pre-Condition Water temperature delivered to the pads during therapy. The Pre-Condition Water feature cools or warms the Reducing the high water temperature limit may be water to a set temperature prior to starting patient therapy.
  • Page 27 English The current Operator’s Manual can be found at www.medivance.com/manuals • Press the Save button to save the new setting and close THERAPY SETTINGS (Continued) the window. Press the Cancel button to close the window without saving the new settings.
  • Page 28 Operator’s Manual THERAPY SETTINGS (Continued) • Press the Save button to save the new setting and close the window. 12. Temperature Units • Use the Temperature Units to select to have either °C or Press the Cancel button to close the window without °F as the default temperature units displayed on the saving the new settings.

  • Page 29: Advanced Setup

    English The current Operator’s Manual can be found at www.medivance.com/manuals • See the following table for the contents of the data file. ADVANCED SETUP During therapy, the values for each parameter are saved Use the Advanced Setup screen to view the current settings every minute.
  • Page 30 Operator’s Manual ADVANCED SETUP (Continued) Connectivity Settings Total Drain Use Connectivity Settings to connect the Arctic Sun™ The Arctic Sun™ Temperature Management System Temperature Management System to the hospital network needs to be totally drained of water prior to shipping or connection.
  • Page 31 English The current Operator’s Manual can be found at www.medivance.com/manuals ADVANCED SETUP (Continued) Current Date To set the current local date: • From the Advanced Setup screen, press the button to the Number Format right of the Current Date parameter.

  • Page 32: Alarms

    Operator’s Manual VII. ALARMS Non-Recoverable Alarms The Arctic Sun™ Temperature Management System safety If an Alarm condition occurs that prevents proper use of the system continually monitors the state of the device and the device or proper patient treatment (such as the five main safety patient, and issues alarms to notify the user of conditions that alarms discussed above), the system is placed into Stop mode may interfere with patient safety or system performance.

  • Page 33: Troubleshooting

    English The current Operator’s Manual can be found at www.medivance.com/manuals Extended Cold Water Exposure VIII. TROUBLESHOOTING Exposure of the skin to low or high water temperatures for an extended period of time may increase the risk for skin injury. WATER The clinician should monitor the patient and water temperatures displayed on the Arctic Sun™...

  • Page 34: Extended Warm Water Exposure

    Operator’s Manual WATER (Continued) • Make Clinical Decision • Make Clinical Decision ◦ If all of the above considerations have been ◦ If all of the above considerations have been addressed and the patient still has not reached target addressed and the patient still has not reached target temperature the physician and nursing staff make a temperature the physician and nursing staff make a clinical decision to limit the warm water exposure:...

  • Page 35: No Patient Temperature Display

    English The current Operator’s Manual can be found at www.medivance.com/manuals SCREEN PATIENT TEMPERATURE (Continued) Screen Locked After approximately 2 minutes of inactivity, the screen will lock • Verify patient temperature to prevent inadvertently changing parameters during patient ◦ The patient temperature probe is properly placed and therapy.

  • Page 36: Cleaning And Disinfection

    Operator’s Manual SURFACE DISINFECTION CLEANING AND DISINFECTION Disinfect the Arctic Sun™ Temperature Management System immediately following cleaning. Follow all manufacturers’ SURFACE CLEANING guidelines for the pre-saturated germicidal wipes, including After use, the external surfaces of the Arctic Sun™ wearing gloves and other personal protective equipment when Temperature Management System may be a potential dispensing and using the wipes.

  • Page 37: Maintenance And Service

    English The current Operator’s Manual can be found at www.medivance.com/manuals MAINTENANCE AND SERVICE 2) Refill the reservoir. • Connect the fill tube. • From the Hypothermia therapy screen or the Routine maintenance and service should be performed on the Arctic Sun™ Temperature Management System Control Normothermia therapy screen, press the Fill Reservoir Module every 6 months at a minimum.

  • Page 38: Service

    The operator will be informed of preventative maintenance through the notification icon on the therapy screen. See section VI. Operation Guide–Therapy Screens–Notification for additional detail. For additional information, please refer to http://www.medivance.com/manuals, call 1-800-526-4455 or contact your local BD representative.

  • Page 39: Appendix A: Electromagnetic Compatibility

    English The current Operator’s Manual can be found at www.medivance.com/manuals APPENDIX A: ELECTROMAGNETIC 1.2 EN/IEC 60601-1-2 Table 2 COMPATIBILITY Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The EUT is intended for use in the electromagnetic environment specified below. Medical electrical equipment needs special precautions The customer or user of the EUT should ensure that it is used in such an regarding electromagnetic compatibility.
  • Page 40 Operator’s Manual The Arctic Sun™ Temperature Management System unit is intended for use in Test Band Service Modulation Distance Immunity Power the electromagnetic environment specified below. The customer or the end freq. (MHz) Test user of the Arctic Sun™ Temperature Management System should assure it is (MHz) Level used in such an environment.

  • Page 41: Appendix B: Alarms

    English The current Operator’s Manual can be found at www.medivance.com/manuals APPENDIX B: ALARMS Alarm Problem Solution 00 Communications Turn Control Module Off. Wait 30 seconds and turn Control Module Failure Communications to control panel Medium Priority have failed upon power up If alarm persists, contact BD Customer Support.
  • Page 42 Operator’s Manual Alarm Problem Solution Verify Patient Temperature Accuracy § Confirm patient temperature using a secondary site. § Confirm that the primary temperature probe is properly placed and registering an accurate temperature. Verify Patient / Water Temperature Control § Observe patient temperature Is the patient temperature decreasing? §...
  • Page 43 English The current Operator’s Manual can be found at www.medivance.com/manuals Alarm Problem Solution Verify Patient Temperature Accuracy § Confirm patient temperature using a secondary site. § Confirm that the primary temperature probe is properly placed and registering an accurate temperature.
  • Page 44 Operator’s Manual Alarm Problem Solution Check that the Temp In 1 probe is properly placed in the patient and has not dislodged. Check that the Temp In 1 probe is connected to the Temp In 1 cable / Temp In 1 probe is not detected, or connector on the back of the Control Module.
  • Page 45 English The current Operator’s Manual can be found at www.medivance.com/manuals Alarm Problem Solution Verify Patient Temperature Accuracy § Compare to Temp In 1 reading. § Confirm patient temperature using a secondary site. § Confirm that the secondary temperature probe is properly placed and registering an accurate temperature.
  • Page 46 Operator’s Manual Alarm Problem Solution Verify Patient Temperature Accuracy § Compare to Temp In 1. § Confirm patient temperature using a secondary site. § Confirm that the primary temperature probe is properly placed and registering an accurate temperature. Verify Patient / Water Temperature Control §...
  • Page 47 English The current Operator’s Manual can be found at www.medivance.com/manuals Alarm Problem Solution Check that the Patient Temperature 2 probe is properly placed in the patient and has not dislodged. Check that the Patient Temperature 2 probe is connected to the...
  • Page 48 Operator’s Manual Alarm Problem Solution Check flow rate. A low flow rate or fluctuating flow rate may cause the 36 Water Temperature The secondary outlet water water to overheat. If the flow rate is low, VIII. Troubleshooting- High temperature is above 44°C Water-Low Water Flow for troubleshooting assistance.
  • Page 49 English The current Operator’s Manual can be found at www.medivance.com/manuals Alarm Problem Solution Verify patient temperature from a secondary site. If patient temperature is less than 31°C (87.8°F), use Manual Control to raise patient temperature above 32°C (89.6°F) then resume using the previous control mode.
  • Page 50 Operator’s Manual Alarm Problem Solution Verify the custom parameters. § Patient target is set to the correct temperature. See VI. Operation Guide–Therapy Screen–Hypothermia Therapy–Cooling or Normothermia Therapy – Control Patient for instructions on setting patient target temperature. § One of the automatic patient control modes (e.g. Control Patient or Cooling) is activated.
  • Page 51 English The current Operator’s Manual can be found at www.medivance.com/manuals Alarm Problem Solution 66 Non-Recoverable Unable to disable pump power Turn Control Module Off. Wait 30 seconds and turn Control Module System Error (Control processor). Medium Priority If alarm persists, contact BD Customer Support.
  • Page 52 Operator’s Manual Alarm Problem Solution 99 Non-Recoverable Turn Control Module Off. Wait 30 seconds and turn Control Module System Error Program unexpectedly aborted. Medium Priority If alarm persists, contact BD Customer Support. Alarm The system is unable to save the Re-try to save the default settings in Advanced Setup screen.
  • Page 53 English The current Operator’s Manual can be found at www.medivance.com/manuals Alarm Problem Solution The data file which contains the All user defined settings in Advanced Setup, Normothermia Settings and 110 Data File Not system default settings has been Hypothermia Settings should be reset by the user prior to the next patient Readable corrupted.
  • Page 54 Operator’s Manual Alarm Problem Solution 117 Patient Verify that the Temp In 1 probe is correctly positioned and correctly Temperature 1 Patient Temperature 1 has not connected to the system. Change Not Detected changed by more than 0.15°C for Verify patient temperature by an independent measurement. Medium Priority an extended period of time.

  • Page 55: Appendix C: Warranty

    English The current Operator’s Manual can be found at www.medivance.com/manuals APPENDIX C: WARRANTY Limited Warranty Bard Medical Division, C. R. Bard, Inc. (“Bard”) warrants to the original purchaser that each Arctic Sun™ Control Module (“Equipment”) and ArcticGel™ Pad (“Disposables”) will be free of defects in workmanship and materials for the period set forth in the labeling and if no such period is set forth, then one year from the date of purchase.
  • Page 56 © 2019 BD. BD and the BD Logo are trademarks of 321 South Taylor Avenue, Suite 200 Becton, Dickinson and Company. Louisville, CO USA 80027 303.926.1917 Phone Bard, ArcticGel, Arctic Sun, and Medivance are 800.526.4455 Toll Free trademarks and/or registered trademarks of Becton, 866.840.9776 Urgent Clinical Help Dickinson and Company.
  • Page 57 English The current Operator’s Manual can be found at www.medivance.com/manuals PK2800300 MM/YYY...

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