Essential Device Performance; Component Identification - Maxtec MaxO2 ME+p Instructions For Use Manual

Indication for Use:
The MaxO ME+p is an oxygen monitor with integrated pressure monitoring intended for con-
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tinuous monitoring of the concentration of oxygen and pressure being delivered to patients
ranging from newborns to adults. It can be used in the hospital and subacute settings. The
MaxO ME+p is not intended as a life-supporting device or life sustaining device.
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1.2 Essential Device Performance
Essential performance are the operating characteristics of the device, without which would
result in an unacceptable risk. The following items are considered essential performance:
Oxygen measurement accuracy
•
Pressure measurement accuracy
•
Operation of visible and audible alarms
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1.3 Component Identification
1 LOW ALARM LED — In a low alarm condition, the yellow "LOW ALARM" LED will flash once
every two seconds, accompanied by the audio buzzer. If the Oxygen level is below 18%,
the red "LOW ALARM" LED will flash twice per second accompanied by the audio buzzer.
2 HIGH ALARM LED— In a high alarm condition, the yellow "HIGH ALARM" LED will flash
once every two seconds accompanied by the audio buzzer.
3 PRESSURE MONITOR PORT — This port is used for connecting pressure monitoring line
for pressure monitoring.
4 COILED CABLE — The coiled cable allows the sensor to be positioned up to 8 feet from the
side of the unit.
5 OXYGEN SENSOR WITH DIVERTER — The sensor (with diverter) is designed to fit industry
standard, 15mm I.D. "T" adapters.
6
CALIBRATION KEY — This key is used to calibrate or zero the device. The device
must be in the unlocked state for the key to operate. See section 2.3 for instructions on
calibrating.
7 UP (ALARM HIGH) — The up key is used in setting the high alarm limit. The device
must be in the unlocked state for the key to operate. See section 3.1.2 for instructions on
setting the high alarm limit.
8 UNLOCK KEY — The unlock key is used to unlock and lock the instrument.
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BACKLIGHT — The backlight key will manually activate the backlight for 30 sec-
onds. See section 3.4 for more information on backlighting operation.
q ALARM SILENCE KEY —
In an alarm condition, pressing the SILENT key will deacti-
vate the audible alarm for 2 minutes.
w ON/OFF AND MODE KEY —
the device OFF, the button must be held while a rapid 3-2-1 countdown takes place to
prevent accidental power-off. This button is also used to toggle between oxygen (O2)
and pressure (P) modes when the device is unlocked.
e DOWN (ALARM LOW) — The down key is used in setting the low alarm limit. The
device must be in the unlocked state for the key to operate. See section 3.1.1 for instruc-
tions on setting the low alarm limit.
r SMART ALARM KEY — The smart alarm key is used to help set the High-Low Alarm
window quickly. This automatically sets oxygen alarms at ±3% or pressure alarms at
±2 cmH O.
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ENGLISH
This key is used to turn the device on or off. To turn
t
EXTERNAL POWER SUPPLY PORT — The port provides connection for the external power
supply. See section 3.6 for more information on the power adapter.
y LCD DISPLAY—The liquid crystal display (LCD) provides direct readout of oxygen con-
centrations and pressures. The digits also display error codes, alarm set modes and
calibration codes as necessary.
u PRESSURE READING — Current pressure reading of the sample in centimeters of water
(cmH O).
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i
HIGH PRESSURE ALARM LIMIT — High pressure alarm setpoint. Audible and visual
alarms will trigger when this limit is exceeded. Double dashes (--) indicates the alarm is
inactive.
o OXYGEN CONCENTRATION — Current oxygen concentration percentage from the oxygen
sensor.
p
HIGH ALARM INDICATOR —
setpoints and when a high alarm is triggered.
a OXYGEN HIGH ALARM LIMIT — High oxygen alarm setpoint. Audible and visual alarms will
trigger when this limit is exceeded. Double dashes (--) indicates the alarm is inactive.
s POWER SUPPLY INDICATOR — Indicates when the device is connected and receiving
power from an external power supply. NOTE: Batteries are still required for proper
operation.
d CALIBRATION REMINDER —
tom of the display. This symbol will be lighted after one week has elapsed from the
previous oxygen calibration.
f BATTERY INDICATOR —
play and bars indicate approximate battery level remaining.
g
ALARM SILENCE/SMART ALARM INDICATOR — When the silent key
indicator will display with cross bars
Button is pressed the indicator will display with T-bars
h OXYGEN LOW ALARM LIMIT — Low oxygen alarm setpoint. Audible and visual alarms will
trigger when this limit is exceeded.
j
LOW ALARM INDICATOR —
setpoints and when a low alarm is triggered.
k <18% ALARM INDICATOR — The <18% alarm indicator is located above the Low Alarm
Indicator digits. When the low alarm setting is set below <18%, the indicator will flash
each second to alert the operator of this special condition. See section 3.1.1 for setting
this low alarm condition.
l LOW PRESSURE ALARM LIMIT — Low pressure alarm setpoint. Audible and visual alarms
will trigger when this limit is exceeded. Double dashes (--) indicates the alarm is
inactive.
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High alarm symbol used for identifying the high alarm
The calibration reminder symbol is located at the bot-
The battery indicator is located at the bottom of the dis-
to alert condition. When Smart Alarm Mode
to alert condition.
Low alarm symbol used for identifying the low alarm
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is pressed the