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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 Arctic Sun™ Temperature Management System Service Manual for
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 Arctic Sun™ Temperature Management System is a thermoregulatory 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 Arctic Sun™ Temperature Management System consists
of the Control Module and disposable ArcticGel™ Pads.
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 Arctic Sun™ Temperature Management System pulls temperature-
controlled water ranging between 4°C and 42°C (39.2°F and 107.6°F) through
the ArcticGel™ Pads at approximately 0.7 liter per minute per pad. This results in
heat exchange between the water and the patient.
The Arctic Sun™ Temperature Management System Control Module is a
CLASS I mobile device (Type BF, IPX0 and Mode of Operation – Continuous) per
classification scheme of IEC 60601-1.
The Arctic Sun™ Temperature Management System Control Module meets 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 Arctic Sun™ Temperature
Management System Control Module associated with electromagnetic
interference from other devices. See the Arctic Sun™ Temperature 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 Bard Supplier or Distributor to arrange for disposal.
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