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PlasmaFlow Label Symbol Descriptions
Caution
Federal Law (U.S.A.) restricts this device to sale, distribution or use by or on the order of a physician or properly licensed
practitioner. PlasmaFlow is only intended for the use by the individual for whom it was prescribed. The device is ONLY for
single patient use.
THIS DEVICE IS NON-STERILE
PlasmaFlow does not require sterilization before use.
The use of accessories, power supplies and cables other than those specified, with the exception of components
sold by the manufacturer of the PlasmaFlow
™
as replacement parts, may result in increased emissions or
decreased immunity of the PlasmaFlow.
Designates Class II medical electrical equipment.
This unit is an electromechanical device that includes printed circuit boards and rechargeable
batteries. Do not discard in landfill. Consult local county requirements for proper disposal instructions.
This symbol designates the degree of protection against electrical shock
from the wrap as being a type B applied part.
Consult instructions for use.
CAUTION: Federal Law restricts this device to sale by or on the order of a physician.
Technical Data
Device Box Components
PlasmaFlow Take-Home DVT Device (2)
PlasmaFlow Charger
Power Supply
Class II Input: 100 – 240 Vac, 50-60 Hz. Output: 5 V at 1 Amp
Use only UL/60601-1 approved power supplies
from ManaMed for use in hospital settings.
Output: Mode of Operation Continuous
Specifications
Dimension: 23’ x 10.25” x 1.5’ (58cm x 26cm x 4 cm)
Weight: Approximately 1.43 lb (.65 kg)
Modes of Operation: Mode 1 and Mode 2
Source of Power: DC 5 V or Inner Battery
(3.7volt Lithium-Ion Battery)
System Operating Environment:
Temperature: 50oF (10oC) and 104oF (40oC)
Humidity: 30%-75%. Keep dry.
Default Settings
Leg Pressure (not adjustable): 55mmHg
Cycle time: 60 Seconds
Mode One: Slow Inflation
Mode Two: Set Up Technology
Tolerance
Pressure 5%