50
Service Manual
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).
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
40°C (39.2°F and 104°F) through the ArcticGel™ pads. 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 Appendix C for the full declaration regarding
electromagnetic compatibility.
Environmental Conditions
At operating temperatures higher than 27°C (80.6°F), the
refrigeration system’s cooling capacity and therefore its
ability to cool a patient is compromised.
If the Control Module is to be exposed to subfreezing
temperatures, perform the Total Drain process. See
Chapter 8- Drain the Control Module, Total Drain
, for
further instructions.
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
Normothermia: Control Patient,
Rewarming
Hypothermia: Cooling, Rewarming
Heater Maximum Power 814 Watts
Circulating Fluid
Sterile Water with Cleaning Solution
Reservoir Capacity
3.5 liters
Patient Probe Type
YSI 400 Series compatible
Patient Temperature
Inputs
Temp In 1: control, monitor, alarm
Temp In 2: monitor, alarm
Patient Temperature
Display Range
10°C to 44°C/50°F to 111.2°F
0.1°C/°F increments
Patient Temperature
Measurement Accuracy
±0.4°C (10°C to 32°C/50°F to 89.6°F)
±0.2°C (32°C to 38°C/89.6°F to 100.4°F)
±0.4°C (38°C to 44°C/100.4°F to 111.2°F)
Excludes external probe
Responses of the PCLCS
(Physiologic Closed-Loop
Control System)
Settling Time: ~4.5 hours
Relative Overshoot: <0.5°C
Command Overshoot: <0.5°C
Warming (max) Response Time:
32°C to 37°C/91.4°F to 98.6°F : ~8.5 hours
Cooling Response Time:
37°C to 33°C/98.6°F to 91.4°F: ~2 hours
Steady State Deviation: 0
Tracking Error: 0
Note: All values derived from testing in
simulated use
Patient Temperature
Control Range
32°C to 38.5°C/89.6°F to 101.3°F
0.1°C/°F increments
Water Temperature
Display Range
3°C to 45°C/37.4°F to 113.0°F
0.1°C /°F increments
Water Temperature
Control Range (Manual)
4°C to 40°C
1°C increments
High Water
Temperature Limit
36°C to 40°C
1°C increments
Low Water Temperature
Limit
4°C to 25°C
1°C increments
Time to heat water
from 25°C to 40°C
<15 minutes
Time to lower water
temperature from 25°C
to 7°C
<15 minutes
Sound Pressure
Low Priority Alarm: 64-71dB at 1 meter
Medium Priority Alarm: 64-71dB at 1 meter
Reminder Tone: 65dB at 3 meters
Mains Input
120VAC 60Hz 11Amp
Total Patient Leakage
Current (Normal
Condition)
<300 μA
Operating Relative
Humidity Range
5% to 70% non-condensing
Storage and Transport
Relative Humidity Range 5% to 95% non-condensing
Operating Temperature
Range
15.5°C to 32.2°C/59.9°F to 90.0°F
Storage and Transport
Temperature Range
-30°C to 50°C/-22°F to 122°F
Atmospheric Pressure
Range
60 kPa to 101 kPa
Dimensions
Height: 41 inches (104 cm)
Width: 16 inches (41 cm)
Depth: 20 inches (51 cm)
Weight
Filled: 55.3 kg/122 lbs
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