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Chapter 9 – Calibration / Calibration Check
9.1 Calibration Test Unit
The Arctic Sun™ Temperature Management System
Calibration Test Unit (CTU) is an instrument that is
purchased separately and is used to calibrate and verify
operation of the Arctic Sun™ Temperature Management
System
Control Module. It connects directly to the
Inlet/Outlet Manifold
and temporarily replaces the
Fluid Delivery Line. Cables from the CTU connect to
the Temp In 1, 2 and Temp Out connectors. The CTU is
used to semi-automatically calibrate the two patient
temperature circuits, the Patient Temperature Out
circuit, and the four water temperature circuits. It is
also used to verify the flow rate and inlet pressure
circuits. Correct operation of the water over-temperature
alarm can also be verified manually using this device.
Optionally, just a check of the current calibration can be
performed.
English
The current Service Manual can be found at www.medivance.com/manuals
Fig. 9-1 Calibration Test Unit
For the theory of the operation of the calibration
process, please refer to the CTU Operator’s Manual that
is included with the CTU.
9.2 When to Perform a Calibration or Calibration Check
1. Calibration is recommended after 2000 hours of
operation or 250 uses, whichever occurs first. The
status of Calibration is available in the
Advanced
Settings
screen.
2. In addition, Calibration may be required after
replacing certain components (see Chapter 8).
3. Calibration should be done only by trained service
personnel.
4. A Calibration Check confirms the device flow, ability
to heat and cool, and the temperature sensing
systems are all within specification. During the
calibration check errors may be displayed with
diagnostic information assisting with performance
or calibration issues. After successful completion of
a calibration check, a report is displayed showing a
pass or fail status of all parameters checked.
9.3 Calibration Setup
1. Remove fluid delivery line by flipping latch from
right to left and attach CTU to Arctic Sun™ device.
Lock in place by flipping latch from left to right.
2. Attach the three cables coming from the CTU to
PT1, PT2, and T0.
9.4 Performing a Calibration
To perform a calibration on the Arctic Sun™ Temperature
Management System, press the
Advanced Setup
button on
the
Therapy Selection
screen. Press the
Start
button next
to Begin Process in the Calibration section and follow the
on-screen instructions.
Chapter 10 - 2,000 Hour Service
Use of the Arctic Sun™ Temperature Management System
in excess of 2,000 hours without conducting maintenance,
may result in failure of certain system components
and failure of the system to function as intended. A
maintenance message will appear on the System Access
screen indicating preventative maintenance is due. To
maintain system performance, the Arctic Sun™ Temperature
Management System requires periodic service and/or
replacement of the following key components.
o Circulation Pump - 403077-00
o Mixing Pump - 403076-00
o Heater - 403074-00
• Refer to Chapter 8 for component replacement
instructions.
• Perform general maintenance steps per Chapter 4.
• Select the “Maintenance Reset” button on the
Advanced Setup screen to set the maintenance hours
on the system back to zero (0). This step shall be done
post software install if one is required.
• A functional verification (Chapter 1) and calibration is
required after the completion of 2,000-hour Service.
Refer to Chapter 9 for calibration instructions.
• A qualified person familiar with electrical safety testing
setups shall upon completion of Servicing, perform
an electrical safety test per IEC62353 or IEC 60601-1
Class I type BF requirements, or as per local hospital
procedures direct.
• Complete applicable service record documenting service
performed
