Gambro Cobe Spectra, Essentials Manual

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Installing, Transporting, and Returning the Spectra System
COBE
®
Spectra™ Apheresis System • Essentials Guide 3-5
Transporting the Spectra System
The Spectra system is portable. You do not need to re-assemble or
re-install the system after moving it, nor do you need to perform
requalification or other validation on the system before performing
apheresis procedures. Use reasonable methods of protecting the system
to ensure it is not damaged during transport. There are no temperature
restrictions for transporting the system.
The system performs the following self-checks to ensure proper
function:
•
When the power is turned on the system tests the internal
electronics, microprocessor communications, and voltages. Any
problem triggers an alarm.
•
During Prime mode, the system checks all valves, sensors, and
pumps. Any problem triggers an alarm.
•
At the end of Prime mode, you may initiate alarm tests that check
the function of the return valve, the leak detector, door latches, and
access and return pressure sensor alarms. See Chapter 7, “Alarm
Tests,” for more information. Gambro BCT recommends that you
perform the alarm tests after moving the Spectra system.
As long as the system passes the above tests, you may connect the donor
or patient. No further calibration is required.
Storing the Spectra System
To prepare the Spectra system for long-term storage, perform the
following:
1
Wipe the outside of the system with a damp cloth to remove all
dust.
2
Clean and dry the interior of the centrifuge chamber around the
centrifuge.
3
Cover the entire system with a cotton cloth or Spectra system cover
and secure the cover with tape.
Returning the Spectra System
To return the Spectra system to Gambro BCT for any reason, you must
obtain a returned goods authorization (RGA) number from
Gambro BCT before shipment.
To obtain an RGA number and shipping instructions, customers in the
U.S. should contact the Gambro BCT Returned Goods Coordinator,
Quality Assurance Department. Customers outside the U.S. should
contact their local Gambro BCT representative.
Note: Rotate the control panel downward 90
°
when moving the
Spectra system.
Note: The Spectra system must be stored in a pest-free
environment with temperature between -18° C and +60° C (0° F
and 140° F). Ambient storage humidity must be 0% to 80%,
noncondensing.
Caution: The health care institution is responsible for adequately
preparing and identifying product for return shipment. Local
regulations may restrict or prevent shipment of products
contaminated with biohazardous material.