Spectra Optia Apheresis System Operator’s Manual
9
Preface
1
Cautions for Use
System cautions
1
Federal law (USA) restricts this device to sale by or on the order of a physician.
2
Each operator should be thoroughly familiar with the Spectra Optia system’s operating instructions before
using the system. All procedures should be performed by qualified medical personnel under the supervision
of a physician.
3
The Spectra Optia system and the Seal Safe system comply with all relevant international standards
concerning electromagnetic emissions and compatibility. Before undergoing apheresis, patients with active
implantable medical devices should review the implant manufacturer’s instructions for any cautions or
contraindications concerning the use of and/or proximity to devices that emit electromagnetic energy.
Examples of active implantable devices include cardiac pacemakers and cardioverter defibrillators, cochlear
implants, vagus nerve stimulators, and devices that stimulate the peripheral or central nervous systems. This
caution also extends to other devices that may be connected to the patient such as ECG equipment and
infusion systems. Care should be taken to prevent the Seal Safe system from touching the patient or any
cables of the devices that may be connected to the patient.
4
Do not use the Spectra Optia system under any of the following conditions:
•
Power cords, plugs, or receptacles are damaged or worn.
•
Switches are loose.
•
System has received a physical shock, or liquid has spilled on the electronics housed under the cover.
•
Anyone has received an electrical shock while using the system.
•
System appears to be overheating.
5
Keep hair, fingers, clothing, and other articles away from pumps and valves to avoid entanglement.
6
Do not put open containers containing fluid on the device. Fluid spills can contribute to electrical and
mechanical hazards.
7
To avoid damage to the Spectra Optia system, do not operate the centrifuge without a filler installed or
before loading the channel.
8
Before installing a filler or loading a tubing set, inspect the filler and visible interior of the centrifuge
chamber for fluid spills or structural damage. Ensure the metal band around the perimeter of the filler is
centered and secure.
9
To avoid damage to the centrifuge and the filler, do not operate the centrifuge if the filler latch is not lowered
and locked in place. Ensure that the filler cannot be pulled off the gear train without unlocking and raising
the filler latch.
10
To avoid personal injury or damage to the system, use proper lifting techniques when lifting the
Spectra Optia system.
11
Ensure that the wheel pedal is pressed to the right side (locked position) and the rear wheel brake levers are
locked during procedures, so that the Spectra Optia system does not move.
12
When the wheel pedal is not in the locked position (pressed to the right side) and the rear wheel brake levers
are released, ensure at least one person is in continuous contact with and controls the movement of the
Spectra Optia system.
13
Only perform procedures when the system is on a smooth, dry, level surface.
14
Do not leave the device unattended in a traffic area.
SpectraOptiaOpsManual.book Page 9 Thursday, May 17, 2018 11:24 AM
