Arthrex Angel, Operator'S Manual

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Technical Data
7-2
Angel ® cPRP System Operator’s Manual
Characteristic Performance Condition
Operating Atmospheric
Pressure
70 kPa to 106 kPa
Storage Temperature -20° to 37.7°C
(-4° to 100°F)
Storage Humidity
10 to 90% Non-condensing
Storage Atmospheric
Pressure
50 kPa to 106 kPa
Ingress Protection IPX0
Fuse Rating
2x F 5A L, 250V
Restrictions Not to be used in an
explosive atmosphere
Guidance and manufacturer’s declaration – electromagnetic emissions
The Angel System is intended for use in a professional healthcare facility environment, details for
the electromagnetic environment are specified below. The operator of the Angel System should
assure that it is used in this environment. If the Angel System is used within these prescribed
environments, the system will continue to process whole blood or a mixture of whole blood and
bone marrow without manufacturer service.
Emission test Compliance Level
Electromagnetic
environment -
guidance
RF emissions CISPR 11 used for domestic
Group 1
The Angel System uses
RF energy only for its
internal function.
Therefore, its RF
emissions are very low
and are not likely to
cause any interference
in nearby equipment.
RF emissions CISPR 11 A The Angel System is
suitable for use in all
establishments other
than domestic and
those directly connected
to the public low-voltage
power supply network
that supplies buildings.
Harmonic emissions
IEC 61000-3-2
A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
Warning: The emissions characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 Class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required) this equipment might not offer adequate protection to
radio-frequency communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
Warning: Use of the Angel System adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.