Preface
8
Spectra Optia Apheresis System Operator’s Manual
57
Terumo BCT, Inc. (Terumo BCT Ltd.) products bearing the DEHP symbol contain phthalates (DEHP).
Whole blood donors are not exposed to DEHP; the potential health risk to apheresis donors is low, because
the time-averaged DEHP dose exposure is very low. Patient groups that include pregnant or nursing women
and children are considered to be the most at risk to potential harmful effects of exposure to DEHP.
However, regulatory bodies have noted that the benefit of doing a needed procedure is far greater than the
risk associated with exposure to DEHP. It is the responsibility of the treating physician to balance this risk
for the patient.
Accessory set warnings
58
Use only the Spectra Optia BMP Accessory Set when performing a BMP procedure on the Spectra Optia
system. The system’s performance has not been validated using other accessories.
Fluid warnings
59
When using biologically-derived replacement fluids, closely monitor the patient for reactions.
60
Use only the fluids specified in this manual when performing procedures on the Spectra Optia system. Using
a fluid with a different composition or concentration could cause hemolysis.
61
Before using hydroxyethyl starch (HES) for a procedure performed on the Spectra Optia system, consult the
manufacturer’s package insert for potential contraindications and adverse events.
Seal Safe system warnings
62
Use only the sealer head and radio frequency (RF) cable provided by Terumo BCT with the Seal Safe system.
The Seal Safe system does not function correctly with components from other tubing sealers.
63
Do not seal the tubing within 8 cm (3 in) of the needle, or you may cause a burn at the needle entry point.
64
Do not place your fingers within 2.5 cm (1 in) of the Seal Safe system’s sealing jaw, or you may receive a
radio frequency (RF) burn.
65
Do not release the lever of the sealer head until after the indication light goes out. Releasing the lever sooner
could result in an inadequate seal.
66
Ensure that the sealer head and the tubing are free of moisture and debris before using the Seal Safe system.
67
Moisture on the surface of the tubing or the sealer head may cause an electrical arc to occur between the jaws
when the power is applied, terminating the sealing process. If an arc occurs, carefully inspect the seal to
ensure it is satisfactory.
68
Ensure that there is no tension on the tubing when operating the Seal Safe system. Stretching the hot tubing
could cause a leak.
69
Do not submerge the Seal Safe system in liquid or you may receive an electric shock.
70
Disconnect the sealer head from the RF cable before cleaning to avoid receiving a serious radio frequency
(RF) burn during the cleaning process.
71
The jaw on the sealer head contains an indentation where the spring rests. If you do not properly seat the
spring in the indentation after cleaning, you may damage the spring, which could cause inadequate tubing
seals.
72
Do not open the sealer head to service the device or you may receive an electric shock. Contact a qualified
service representative to service the device.
SpectraOptiaOpsManual.book Page 8 Thursday, May 17, 2018 11:24 AM