Arthrex Angel, Operator'S Manual

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Overview
Angel ® cPRP System Operator’s Manual
ix
result in loss of sterility of the device or loss of blood product.
17. Use of this product for pediatric patients is at the discretion of a physician. Blood
withdrawal from a pediatric patient should be performed in the presence and at
the direction of a physician to prevent significant reduction of the circulating blood
volume.
18. When collecting and processing autologous blood products, it is recommended
that the following precautions be followed to insure that the autologous product is
not contaminated:
• Use sterile technique when setting up the Angel Processing Set
• Thoroughly clean and disinfect the donation site
• Use sterile technique whenever handling autologous blood products
19. The whole blood or the mixture of blood and bone marrow must be anticoagulated
before it can be processed for separation. Inadequate anticoagulation may result in
clotting, interfering with the processing of the blood products. Blood containing
clots will not pass through the syringe-activated valve located on the Whole Blood
Compartment of the Three-Compartment Reservoir Bag.
20. Failure to properly load the Centrifuge Plate prior to processing, may lead to
exposure to blood and blood-borne pathogens.
21. If centrifugation is discontinued before the completion of a processing cycle, the
Variable Volume Separation Chamber is pressurized and presents the risk for
exposure to blood and blood-borne pathogens if the Variable Volume Separation
Chamber is not properly removed. Please refer to “
Stop Button
” on page 3-26
for emptying a Variable Volume Separation Chamber containing blood.
22. If a power loss occurs, and there is blood or a mixture of blood and bone marrow
in the Variable Volume Separation Chamber, follow the instructions under
“ Power Loss ” on page 3-27.
23. Failure to properly secure the Luer Lock Syringe to the Valve Assembly may
result in a leakage of fluids.
24. Do not connect the patient directly to the Three-Compartment Reservoir Bag. A
direct connection to the patient could lead to vascular damage, shock, or an air
embolism.
25. Do not place objects in or on the pump during pump rotation. Damage to the
machine and Angel Processing Set may occur.
26. If the Angel System fails to operate as intended, do not use the separated blood
products.
27. The platelet rich plasma is not intended for transfusion.
28. The
Angel System is not intended to be used by the patient. As such a mains
power switch is not available to the user. In case of an emergency, power from
the unit can be removed by unplugging the unit from the electrical socket.
29. Only devices or cables meeting IEC 60950 and IEC 60601-1 should be
connected to the USB Port. Failure to do so may result in operator shock. All
cables used in conjunction with the device should be no longer than 1 m (3 ft.) in
length. Operators connecting other devices to the USB port must ensure
compliance to the system requirements of IEC 60601-1.
30. Operators connecting other devices to the USB Port must ensure compliance to
the system requirements of IEC 60601-1. Connection of other devices could
result in previously unidentified risk to the patient, operator, or third parties. It is
responsibility of the operator to identify, analyze, evaluate, and control any