Overview
viii Angel
®
cPRP System Operator’s Manual
should be practiced (e.g., gloves, Personal Protective Equipment (PPE), etc.)
when disposing of these items.
3. The use of operating or maintenance procedures other than those published by
the manufacturer, or the use of accessory devices not recommended by the
manufacturer may result in poor equipment performance.
4. The manufacturer will not be responsible for patient safety or equipment
performance if the Angel System is operated in a manner other than specified in
this manual. Medical individuals performing the operations described in this
manual must be properly trained and qualified.
5. Any equipment modifications must be performed by qualified persons and be
approved by the manufacturer in writing.
6. All electrical installations must comply with all applicable local electrical codes
and the manufacturer’s specifications.
7. This equipment, when used with the specified data accessories, meets the
following standards identified below. The user does not need to provide
additional efforts regarding electromagnetic emissions or immunity:
• IEC 60601-1-2
o EN 55011, Class A standards
o EN 61000
• Canadian Warning: This equipment is intended for use by healthcare
professionals only. The Angel System may cause radio interference or
may disrupt the operation of nearby equipment. It may be necessary to
take mitigation measures, such as re-orienting or relocating the Angel
System or shielding the location.
o Use sterile technique when setting up the Angel Processing Set
o Thoroughly clean and disinfect the donation site
o Use sterile technique whenever handling autologous
blood products
8. To avoid the risk of electrical shock, this equipment must only be connected to a
supply mains with protective earth. Do not use alternate power plugs or adapters
that disconnect the safety ground.
9. The operator should never touch the USB port on the Angel System, while at the
same time making contact with the patient, as potential for electrical shock may
result.
10. Place the Angel System on a flat, stable surface. Never try to move the
Angel System while the device is in operation. Failure to comply may result in
damage to the Angel System and injury may result.
11. Do not use the Angel System in the presence of flammable agents as an
explosion and/or fire may result.
12. Do not contact any moving parts of the centrifuge or pump while the Angel
System is in operation. Injury may result.
13. Only Angel Processing Sets are approved for patient use with the Angel System.
14. Do not use the Angel Processing Set if the sterile packaging barrier has been
broken.
15. Carefully examine the Angel Processing Set for damage prior to use. Should any
evidence of damage to the Processing Set be evident, do not use the Angel
Processing Set.
16. Carefully observe the Angel Processing Set for leaks during use. Leakage may
To Next Page
Loading...
Need help?
General
