MicroAire 5020 - Intended Use; Compatible Instruments

4 IM-5025 REV E
Name
Ref#
(ISO 7000)
2
Symbol Description Use Standard
Humidity Limitation 2620
Indicates the range of humidity to which the medical device can
be safely exposed. The humidity limitations shall be indicated
adjacent to the upper and lower horizontal lines.
ISO 15223-1:2012
1
Atmospheric
Pressure
Limitation
2621
Indicates the range of atmospheric pressure to which the medical
device can be safely exposed. The atmospheric pressure
limitations shall be indicated adjacent to the upper and lower
horizontal lines.
ISO 15223-1:2012
1
Temperature
Limitation
0632
>
Indicates the temperature limits to which the medical device
can be safely exposed. The upper and lower limits to temperature
shall be indicated adjacent to the upper and lower
horizontal lines.
ISO 15223-1:2012
1
Do Not Expose to
Stray Magnetic Fields
N/A
Indicates a medical device that is not to be exposed to stray
magnetic elds.
N/A
N/A
N/A Potential Equalization Terminal N/A
N/A N/A Do not allow ngers to contact moving parts. N/A
Prescription N/A
Caution: Federal Law (U.S.A.) restricts this device to sale by or on
the order of a physician (or properly licensed practitioner).
FDA
Title 21, Chapter 1,
Subchapter H,
Part 801.15(F)
Dispose of per
WEEE Directive
2012/19/EU
N/A
Indicates a medical device that is not to be disposed of as
unsorted municipal waste. Medical device is to be disposed of
per WEEE Directive 2012/19/EU.
Council Directive
2012/19/EU
Dispose of per
WEEE Directive
2012/19/EU
N/A
Indicates a medical device that is not to be disposed of as
unsorted municipal waste. Medical device is to be disposed of
per WEEE Directive 2012/19/EU. This symbol is used in place of
the above symbol if the product entered the market after 13
August, 2005.
Council Directive
2012/19/EU
(Symbol: European
Standard EN 50419)
UL symbol N/A
E494242
MEDICAL-GENERAL MEDICAL EQUIPMENT AS TO ELECTRIC
SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY. IN
ACCORDANCE WITH ANSI/AAMI ES 60601-1 (2005) + A1
(2012) + CAN/CSA C22.2 No. 60601-1 (2014) | Control
Number: E494242
UL
Irrigation Pump N/A Indicates Irrigation Pump Function N/A
Irrigation Pause/Run N/A
/
p
Irrigation Pump Pause/Run (Normal Run) N/A
Surgical Instrument N/A Indicates Surgical Instrument Function N/A
Normal Run 5107B
p
Run Direction (Run in Forward or Reverse as Indicated) N/A
Standby 5009
X
Switches Unit In and Out of Standby Mode N/A
Instrument
Speed Adjustment
N/A Press to Adjust Instrument Speed (Variable in Steps) N/A
Irrigation Flow
Adjustment
N/A Press to Adjust Irrigation Flow Rate (Variable in Steps) N/A
Direction of Rotation 0941
R
Indicates Direction of Rotation N/A
Foot Control N/A Indicates Foot Control Related Function N/A