Terumo BCT Quantum Cell Expansion System, Руководство оператора

Страница: 13 / 204

Warnings for Use
The following section includes a complete list of the warnings that apply to the use of the Quantum
system. Although the information may also appear in the other sections of this manual, operators should
read and understand the information in this list before using the system. For specific warnings about a
tubing set, refer to the instructions for use that ship with the tubing set.
System Warnings
1. Do not use the Quantum system under any of the following conditions:
•
Any power cords, plugs, or receptacles are damaged or worn.
• Any switches on the device are loose.
• The device has received a physical shock, or liquid has spilled on the electronics.
• Anyone has received an electrical shock while using the system.
• The device appears to be overheating.
2. Only trained and qualified personnel should move the Quantum device.
3. To avoid the risk of an explosion, the oxygen concentration in the gas supplied to the system must
not exceed 20%.
4. The Quantum system includes an external pressure relief valve rated to 75 psi that is located on the
back of the device. Do not block the valve discharge area. When gas pressures exceed 75 psi, the
relief valve opens and releases high pressure gas. Protect the area from possible contact with
personnel.
5. Do not block the external gas connection located on the back of the device on the bottom
‑
left
corner. This connection also functions as a safety disconnect for the device.
6. Individuals who operate the Quantum system must be appropriately qualified and trained.
7.
Avoid pinching your fingers when opening and closing the incubator door.
8.
Always place the device on a sturdy, even surface so that the device is completely supported, which
reduces the risk of the device falling or slipping off the supporting surface.
9. Use caution when interacting with the Quantum device, because it has moving parts that could
injure fingers and entangle hair, clothing, or other personal articles.
10. Do not lean on or place heavy objects on the incubator door when it is open. Doing so could cause
the device to tip and fall.
11. It is the responsibility of the user to validate the safety and efficacy of the expanded cells for their
intended application. Expanded cell products for use in human subjects or patients must comply
with all applicable country-specific regulatory requirements.
12. If the Quantum system is used in a manner not specified by the manufacturer, the operator
protection systems may not be effective in preventing injury to the operator.
13. It is the responsibility of the user to determine any effect residual EtO may have on cells that are
cultured in the Quantum system.
14. Use only power cords specified by Terumo BCT. The use of inadequately rated cords could
possibly cause property damage or bodily harm.
Preface
1-4 Quantum
®
Cell Expansion System • Operator's Manual for Software Version 2.1