Software Update; Service; Calibration; Appendix A: Product Specifications - Medivance Arctic Sun 5000 Manual Del Operador

TEMPERATURE MANAGEMENT SYSTEM
Inspect Fluid Delivery Line
1. Power On the system
2. From the Patient Therapy Selection screen press the Hypothermia button
to display the Hypothermia therapy screen.
3. From the Hypothermia therapy screen, press the Manual Control button
to open the Manual Control window.
4. Set the Manual Control water target temperature to 28°C and the
duration to 30 minutes.
5. Connect a shunt to a set of fluid delivery line ports.
6. Press the Help button and then press the Help Index button. Select the
topic Maintenance and Service and sub topic System Diagnostics then
press the Display button. Verify that inlet pressure is -7 ± 0.2.
7. Repeat on all valves. If inlet pressure is out of range, replace the two
valves that the shunt is connected to.
8. Ensure that the shunt is removed before device is put back in service.

Software Update

Software updates will be provided on a flash drive. Installation of software
updates will be performed via the USB port on the front of the control module.
The software update feature will automatically initiate if the control module detects
the proper files on a flash drive inserted in the USB port at power On.
To install software update:
1) Insert flash drive into the USB port.
2) An image of a timer will display while the software update in being installed,
and will disappear when the software installation process is completed.
3) After installation, the new software version will display in the Software
Version field in Advanced Setup.

Service

Contact Customer Support for technical support and customer service
instructions to enable appropriately qualified technical personnel to repair those
parts of the equipment that Medivance considers repairable.

Calibration

See A S Temperature Management System Service Manual for
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calibration requirements and instructions. Calibration is recommended after
2,000 hours of operation or 250 uses, whichever occurs first.
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Appendix A: Product Specifications

Technical Description

The A S Temperature Management System is a thermoregulatory
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device that monitors and controls patient temperature within a range of 32°C
to 38.5°C (89.6°F to 101.3°F). The A
System consists of the Control Module and disposable A
A patient temperature probe connected to the Control Module provides
patient temperature feedback to an internal control algorithm which
automatically increases or decreases the circulating water temperature to
achieve a pre-set patient target temperature determined by the clinician.
The A S Temperature Management System pulls temperature-
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controlled water ranging between 4°C and 42°C (39.2°F and 107.6°F)
through the A G Pads at approximately 0.7 liter per minute per pad.
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This results in heat exchange between the water and the patient.
The A S Temperature Management System Control Module is
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a CLASS I mobile device (Type BF, IPX0 and Mode of Operation –
Continuous) per classification scheme of IEC 60601-1.
The A S Temperature Management System Control Module meets
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both the electromagnetic interference and susceptibility requirements of IEC
60601-1, and is compatible with other equipment that also conforms to that
standard. There is no known failure mode in the A
Management System Control Module associated with electromagnetic
interference from other devices. See the A
Management System Service Manual for the full declaration regarding
electromagnetic compatibility.

Environmental Conditions

Temperature Range
Operating: ...................10°C to 27°C (50°F to 80°F)
Storage: ................. -30°C to 50°C (-20°F to 120°F)
At operating temperatures higher than 27°C (80°F), the refrigeration system's
cooling capacity and therefore its ability to cool a patient
is compromised.
Humidity Range (relative humidity, non-condensing)
Operating: .............................................. 5% to 70%
Storage: ................................................. 5% to 95%
Atmospheric Pressure Range:... 60 kPa to 110 kPa
Disposal
Upon end of life, dispose of in accordance with local WEEE regulations or
contact your local B Supplier or Distributor to arrange for disposal.
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O P E R A T O R ' S M A N U A L
S Temperature Management
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G
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S Temperature
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S Temperature
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Pads.