Maxtec MaxO2 ME - Symbol Guide

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Never autoclave, immerse in liquid or expose the MaxO2ME (including sensor) to high tem-
peratures (>50°C). Never expose the device to liquid, pressure, irradiation vacuum, steam,
or chemicals.
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To protect the unit from potential leaky battery damage always remove batteries when the
unit is going to be stored (not in use for 30 days or more) and replace dead batteries with
recognized name brand AA Alkaline batteries.
DO NOT use rechargeable batteries.
DO NOT attempt to replace oxygen sensor or batteries while the device is in use.
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This device does not contain automatic barometric pressure compensation.
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Not for use in an MRI environment.
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Battery replacement by inadequately trained personnel could result in a safety hazard.
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Electrical shock or damage to the equipment may occur if an inappropriate external power
supply is used. Maxtec recommends using only the Maxtec approved external power supply,
as listed in 9.0 Spare Parts and Accessories.
NOTE: The MaxO2ME oxygen monitor has been manufactured with a low alarm setting adjust-
able down to 15% that requires deliberate action to set it below 18%. See section 3.1 Alarm
Setting Procedure.
DO NOT clean or dry the MaxO2ME with a high pressure air gun. Applying high pressure
air to the MaxO2ME may damage components and render the system inoperable.
DO NOT over clean the MaxO2ME. Repeated use of a cleaning agent can cause residue
buildup on critical components. Excessive residue buildup can affect the MaxO2ME's
performance.
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When cleaning the MaxO2ME: DO NOT use harsh abrasives. DO NOT immerse the
MaxO2ME in liquid sterilizing agents or liquids of any kind. DO NOT spray cleaning solu-
tion directly onto the device. DO NOT allow cleaning solution to pool on the device.
DO NOT sterilize the MaxO2 ME. Standard sterilization techniques may damage the
monitor.
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If the MaxO2ME does not function as outlined in section 2.0, contact a Maxtec trained service
technician or Maxtec for service.
DO NOT allow the sensor to come in contact with exhaled patient gases or other potential
sources of contamination. The sensor face cannot be decontaminated if it comes in con-
tact with infectious agents.
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Gas leaks that cause room air to mix with the gas sample may cause inaccurate oxygen read-
ings. Ensure the O-rings on the sensor and flow diverter are in place and intact prior to use.
DO NOT expose the sensor face to liquids or allow humidity to condense on the face of the
sensor as this may impair the function of the MaxO2ME.
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The MaxO2ME and sensor are non-sterile devices.
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Regularly inspect the MaxO2ME and associated components for damage or electrolyte leak-
age prior to use.
DO NOT use if damaged.
DO NOT obstruct alarm.
DO NOT smoke in an area where oxygen is being administered.
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The MaxO2ME may only be calibrated using 20.9% oxygen (room air) or 100% oxygen.
Calibration at other concentrations will result in inaccurate readings.
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The oxygen sensor should be operated in an upright position (sensor face downwards).
Operating the oxygen sensor upside down may cause the sensor to function improperly.
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When using the approved external power supply, functional batteries must also be installed
in the device. The device will not operate solely on the external power supply.
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In the event of exposure to an ELECTROMAGNETIC DISTURBANCE the analyzer may display an E06
or E02 error message. If this occurs, refer to Section 5.0 for instructions to resolve the problem.
SYMBOL GUIDE
The following symbols and safety labels are found on the MaxO2ME:
Attention, consult
accompanying documents
On/O Key
Consult Instructions For Use Calibration Key
Do Not Calibration Reminder
Unlock Key Silent Key
Backlight Key Smart Alarm Key
High Alarm Indicator Low Alarm Indicator
Smart Alarm Mode Indicator Alarm Silence Indicator
Down (Low Alarm) Key Up (High Alarm) Key
Low Battery Indicator Sleep Mode Indicator
Federal law (USA) restricts
this device to sale by or
on order of a physician
Meets ETL Standards
Manufacturer Direct Current
Date of Manufacture Medical Device
Warning
Two means of patient
protection (double insulated)
Caution
Power Supply Meets CEC Tier
3 and EU Phase 2 Standards
Conforms to EU Requirements
Authorized
Representative in the
European Community
For use in dry indoor locations
50°C
(122°F)
5°C
(41°F)
Storage Temperature
Range
Serial Number Catalog Number
Complies with Directive
2011/65/EU
Ingress Protection Rating
Combined UL / CSA Mark Corrosive
Do not throw away. Follow
local guidlines for disposal.
Type B Applied Parts
MR Unsafe