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Operator’s Manual

56

Medivance, Inc.

321 South Taylor Avenue, Suite 200

Louisville, CO USA 80027

303.926.1917 Phone
800.526.4455 Toll Free
866.840.9776 Urgent Clinical Help
[email protected]

© 2019 BD. BD and the BD Logo are trademarks of
Becton, Dickinson and Company.

Bard, ArcticGel, Arctic Sun, and Medivance are
trademarks and/or registered trademarks of Becton,
Dickinson and Company.

Federal Law (USA) restricts this device to sale by or on
the order of a physician.

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Содержание BD Arctic Sun 6000

Страница 1: ...14868...

Страница 2: ...Operator s Manual 2 tube...

Страница 3: ...END THERAPY 24 THERAPY SETTINGS 25 ADVANCED SETUP 29 VII ALARMS 32 MEDIUM PRIORITY ALARMS 32 LOW PRIORITY ALARMS 32 VIII TROUBLESHOOTING 33 WATER 33 Water Not Cooling 33 Water Not Warming 33 Extended...

Страница 4: ...o be supplied Catalogue number Indicates the manufacturer s catalogue number so that the medical device can be identified ISO 15223 1 Reference no 5 1 7 Medical Devices Symbols to be used with medical...

Страница 5: ...t the marked item can be hot and should not be touched without taking care IEC TR 60878 Reference no 0029 Graphical Symbols for Electrical Equipment in Medical Practice Draining emptying To indicate t...

Страница 6: ...p On transport packaging To indicate the correct upright position IEC TR 60878 Reference no 0621 Graphical Symbols for Electrical Equipment in Medical Practice Fragile handle with care On transport pa...

Страница 7: ...t plug To identify a port or plug as meeting the generic requirements of the Universal Serial Bus USB To indicate that the device is plugged into a USB port or is compatible with a USB port IEC 60417...

Страница 8: ...during use of the device WARNING Informs the reader about a situation which if not avoided could result in death or serious injury It may also describe potential serious adverse reactions and safety...

Страница 9: ...recommended to use the following settings Water Temperature High Limit 40 C 104 F Water Temperature Low Limit 10 C 50 F Control Strategy 2 It is recommended to use the Patient Temperature High and Pat...

Страница 10: ...sider increasing minimum water temperature modifying target temperature to an attainable setting or discontinuing treatment For patient warming consider decreasing maximum water temperature modifying...

Страница 11: ...ctions Disposal Upon end of life dispose of in accordance with local WEEE regulations or contact your local BD Supplier or Distributor to arrange for disposal Parameter Specification Therapy Modes Nor...

Страница 12: ...terile Water This is done to suppress microorganism growth in the water reservoir and hydraulic circuit For information regarding safe handling please refer to http www medivance com manuals for the C...

Страница 13: ...rrent Temp In 1 reading to a YSI 400 compatible hospital monitor The Arctic Sun Temperature Management System temperature output cables are available with several connector styles e g Phillips GE Rusc...

Страница 14: ...ior to completion the reservoir will not be full and may requiring filling after fewer patient therapies have been performed 7 Press the Cancel button to close the screen FUNCTIONAL VERIFICATION Certi...

Страница 15: ...the Therapy Selection screen to initiate a New Patient Continue a Current Patient or access the Advanced Setup screen New Patient Normothermia If the therapy goal is to maintain a patient temperature...

Страница 16: ...t Temperature B Patient Temperature 2 if enabled 6 System Status C Water Temperature D Flow Rate 7 Therapy Graph E Patient Temperature F Water Temperature G Date and Time H Progress Bar 8 Empty Pads 9...

Страница 17: ...erature Units if enabled 5 Patient Status C Patient Temperature D Patient Temperature 2 if enabled 6 System Status E Water Temperature F Flow Rate 7 Therapy Graph I Patient Temperature J Water Tempera...

Страница 18: ...ower down is not captured in the Event Log 3 Notification Notifications are active when attention to the system is required e g preventative maintenance When a notification is active a small icon will...

Страница 19: ...mperature graph is divided into 5 segments denoted by time markers 00 00 04 00 08 00 12 00 16 00 and 20 00 During Hypothermia therapy the graph background is color coded to represent the current time...

Страница 20: ...Control Strategy 1 2 3 Range 33 5 C to 38 5 C 92 3 F to 101 3 F 32 5 C to 38 5 C 90 5 F to 101 3 F Increments 0 1 C F 0 1 C F Lower limit Control Strategy 1 2 3 Range 33 0 C to 38 0 C 91 4 F to 100 4...

Страница 21: ...been changed the Arctic Sun Work to Cool Trend graph will be greyed and the icon will display a grey hour glass for a period of 15 minutes 12 Control Settings Normothermia Screen The default patient...

Страница 22: ...end of the range is limited by the current target temperature Rewarm at a Rate of Use the Up and Down arrows in the center of the screen to set the rewarming rate Range 0 01 to 0 50 C hour 0 02 to 0 9...

Страница 23: ...he Save button to save the new settings and close the Control Patient Adjust window 7 Press Start in the Control window to initiate therapy You will hear a tone and then a voice stating Therapy Starte...

Страница 24: ...itiated when the patient reaches the transport destination 9 Plug the Control Module power cord into the wall 10 Power On 11 Connect the patient temperature probes to the Patient Temperature Cables 12...

Страница 25: ...temperature From the Hypothermia Settings screen press the button to the right of the Cooling Begins parameter Select the point that the therapy timer begins Range Immediately At Target Press the Save...

Страница 26: ...ows to select the Manual Control maximum time duration The selected time will be the default time displayed in the Manual Control pop up window Range 15 minutes to 99 hours Increments 15 minutes from...

Страница 27: ...Control Strategy parameter Use the Up and Down arrows to select the control strategy setting Range 1 2 3 Press the Save button to save the new setting and close the window Press the Cancel button to...

Страница 28: ...and close the window Press the Cancel button to close the window without saving the new settings 14 Patient Temperature 2 Use the Patient Temperature 2 setting to enable or disable the Patient Temper...

Страница 29: ...when the process is complete by changing the color of the patient data file text to gray Remove the flash drive from the USB port The data is saved as a text file to the flash drive s main directory...

Страница 30: ...as indicated on the display screen See the Arctic Sun Temperature Management System Service Manual for calibration requirements and instructions Calibration should be done only by trained service per...

Страница 31: ...ate format to the local requirements From the Advanced Setup screen press the button to the right of the Date Format parameter Use the Up and Down arrows to select the date format Range MM DD YY DD MM...

Страница 32: ...l sound All Alarm settings are maintained in the event of a power interruption Non Recoverable Alarms If an Alarm condition occurs that prevents proper use of the device or proper patient treatment su...

Страница 33: ...he Arctic Sun Temperature Management System therapy graph to properly assess the progress of the temperature management therapy Additionally the Arctic Sun Temperature Management System incorporates a...

Страница 34: ...leshooting Water Low Water Flow for troubleshooting instructions Water temperature is responding appropriately to control patient temperature towards the target If not see VIII Troubleshooting Water W...

Страница 35: ...rapid change in core temperature that the system is unable to counteract immediately No Patient Temperature Display Confirm that the patient temperature probe is properly placed in the patient Confir...

Страница 36: ...m immediately following cleaning Follow all manufacturers guidelines for the pre saturated germicidal wipes including wearing gloves and other personal protective equipment when dispensing and using t...

Страница 37: ...odule Place the end of the drain line into a container The water will passively drain into the container 2 Refill the reservoir Connect the fill tube From the Hypothermia therapy screen or the Normoth...

Страница 38: ...e the Arctic Sun Temperature Management System requires periodic service and or replacement of key components The operator will be informed of preventative maintenance through the notification icon on...

Страница 39: ...ronment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Arctic Sun Temperature Management System uses RF energy only for its internal function Therefor...

Страница 40: ...z 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMts Pulse mod 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE band 7 Pulse mod...

Страница 41: ...to clear the line and then check to see if the flow has increased If faulty pad found replace faulty pad 5 To check whether a valve is leaking reinstall the pad into a different location on the fluid...

Страница 42: ...that may affect cooling Are the machine vents blocked Is the room temperature too high Is the oxygen heated Are there hot lights or heating blankets on the patient Remove any impediments Monitor water...

Страница 43: ...m is not working Call BD Customer Support If the water temperature increases to the commanded temperature the water heating system is working 5 Verify Patient Control System Performance Place system b...

Страница 44: ...obe and temperature cable is secure 4 Check that the connection between the temperature cable and the Temp In 1connector is secure 5 Check the integrity of the temperature cable Flex the cable to chec...

Страница 45: ...mental conditions that may affect cooling Are the machine vents blocked Is the room temperature too high Is the oxygen heated Are there hot lights or heating blankets on the patient Remove any impedim...

Страница 46: ...g Call BD Customer Support If the water temperature increases to the commanded temperature the water heating system is working 5 Verify Patient Control System Performance Place system back into the pa...

Страница 47: ...stem is unable to internally check the calibration of the Patient Temperature 2 channel within 1 0 C when the system is in Manual Control mode Patient Temperature 2 channel is made inactive 1 Power sy...

Страница 48: ...riority Alarm One or more of the entries into the system event log is invalid The system event log is used by clinical engineering personnel for product service This issue does not affect the performa...

Страница 49: ...ing is activated The system is not in Manual Control mode The high water temperature limit and low water temperature limits are set correctly See VI Operation Guide Therapy Settings High Water Limit o...

Страница 50: ...water temperature remains below 10 C 50 F then the patient is generating excessive heat most likely from shivering which may or may not be visible Consider administration of additional medication for...

Страница 51: ...and turn Control Module On 2 If alarm persists contact BD Customer Support 77 Non Recoverable System Error Medium Priority Alarm Chiller water temperature sensor out of range high resistance 1 Turn Co...

Страница 52: ...has reached the end of its set duration and Rewarming Begins in Hypothermia Settings is set to Manually See VI Operation Guide Therapy Settings Rewarming Begins for more information Press the Start b...

Страница 53: ...d period of time Prolonged warm water exposure may increase the risk for skin injury Assess patient s skin underneath the ArcticGel pads 1 Verify the custom parameters Patient target is set to the cor...

Страница 54: ...erature by an independent measurement 3 Verify that the rate of temperature change is intentionally set to a low value 119 Patient Temperature 1 Outside of Monitor Mode Limits Low Priority Alarm Patie...

Страница 55: ...S ARISING OUT OF HANDLING OR USE OF BARD EQUIPMENT OR DISPOSABLES EVEN IF BARD HAS BEEN ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SUCH DAMAGES IN NO EVENT WILL BARD S LIABILITY UNDER THIS WARRANTY E...

Страница 56: ...Free 866 840 9776 Urgent Clinical Help arcticsun crbard com 2019 BD BD and the BD Logo are trademarks of Becton Dickinson and Company Bard ArcticGel Arctic Sun and Medivance are trademarks and or regi...

Страница 57: ...The current Operator s Manual can be found at www medivance com manuals English 57 PK2800300 MM YYY...

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