Maxtec MaxO2 ME+p User manual

R230M06 REV. A
MaxO2®
ME+p
Instructions for Use
ENGLISH

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This manual is intended for healthcare professionals. This device should only be used by clini-
cally trained operators with sufficient knowledge, training and understanding of this manual.
This manual describes the function, operation and maintenance of the Maxtec Model MaxO2
ME+p oxygen and pressure monitor. The MaxO2 ME+p utilizes the Maxtec MAX-550E oxygen
sensor and is engineered for fast response, maximum reliability and stable performance. The
MaxO2 ME+p is designed primarily for continuous monitoring of oxygen levels delivered by
medical oxygen delivery equipment and respiratory care systems. Adjustable high and low
level alarm set points make the MaxO2 ME+p ideal for use in neonatal, anesthesia and respira-
tory care.
CLASSIFICATION
Protection against electric shock .............................................................................................Class II
Ingress Protection..........................................................................................................................IPX2
Mode of operation..............................................................................................................Continuous
Sterilization....................................................................................................................See section 7.1
Applied Parts....................................................................................................Type B (Entire Device)
Flammable anesthetic mixture ...................................................................................See section 9.1
Product Disposal Instructions:
The sensor, batteries, and circuit board are not suitable for regular trash
disposal. Be sure to dispose of expired sensors in accordance with hospital,
local, state, and federal regulations, or return to Maxtec for proper disposal or
recovery. Follow local guidelines for disposal of other components. There are
no special considerations for the disposal of the product packaging.
WARRANTY
The MaxO2 ME+p monitor is designed for medical oxygen delivery equipment and systems.
Under normal operating conditions, Maxtec warrants the MaxO2 ME+p monitor to be free from
defects of workmanship or materials for a period of two (2) years from the date of shipment
from Maxtec, provided that the unit is properly operated and maintained in accordance with
Maxtec’s operating instructions. Based on Maxtec’s product evaluation, Maxtec's sole obliga-
tion under the foregoing warranty is limited to making replacements, repairs, or issuing credit
for equipment found to be defective. This warranty extends only to the buyer purchasing the
equipment directly from Maxtec or through Maxtec's designated distributors and agents as
new equipment. Maxtec warrants the MAX-550E oxygen sensor in the MaxO2 ME+p monitor to
be free from defects in material and workmanship for a period of two (2) years from Maxtec's
date of shipment in a MaxO2 ME+p unit. Should a sensor fail prematurely, the replacement
sensor is warranted for the remainder of the original sensor warranty period. Routine mainte-
nance items, such as batteries, are excluded from warranty. Maxtec and any other subsidiaries
shall not be liable to the purchaser or other persons for incidental or consequential damages
or equipment that has been subject to abuse, misuse, mis-application, alteration, negligence
or accident. THESE WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTY OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE.
NOTE: In order to obtain optimum performance from your MaxO2 ME+p monitor, all operation
and maintenance must be performed in accordance with this manual. Please read the manual
thoroughly before using the monitor and do not attempt any repair or procedure that is not
described herein. Maxtec cannot warrant any damage resulting from misuse, unauthorized
repair or improper maintenance of the instrument.
EMC Notice
This equipment uses, generates, and can radiate radio frequency energy. If not installed and
used in accordance with the instructions in this manual, electromagnetic interference may
result. The equipment has been tested and found to comply with the limits set forth in IEC
60601-1-2 for medical products. These limits provide reasonable protection against electromag-
netic interference when operated in the intended use environments described in this manual.
MRI Notice
This equipment contains electronic and ferrous components, whose operation can be affected
by intense electromagnetic fields. Do not operate the MaxO2 ME+p in an MRI environment or
in the vicinity of high-frequency surgical diathermy equipment, defibrillators, or shortwave
therapy equipment. Electromagnetic interference could disrupt the operation of the MaxO2
ME+p.
WARNINGS
FAILURE TOCOMPLY WITH THESE WARNINGS AND CAUTIONS COULD RESULT IN INSTRUMENT
DAMAGE AND POSSIBLY JEOPARDIZE THE WELL BEING OF THE PATIENT AND/OR HEALTH
CARE PROFESSIONAL.
◆ Before use, all individuals who will be using the MaxO2 ME+p must become thoroughly
familiar with the information contained in this Operation Manual. Strict adherence to the
operating instructions is necessary for safe effective product performance. This product will
perform only as designed if installed and operated in accordance with the manufacturer’s
operating instructions.
◆ This product is not intended as a life-sustaining or life-supporting device.
◆ Medical Oxygen should meet the requirements of USP.
◆ The Alarm limits can be set to levels that would render them useless for a particular patient's
clinical condition. Ensure that the delivered oxygen level and flow rate are set to values pre-
scribed by the patient's physician. Also ensure that the high and low alarm limits are set to
levels such that they will sound if the oxygen level is outside of safe limits. Be sure to review
and, if necessary, re-set the alarm limits when the patient's clinical condition changes or
when the patient's physician prescribes a change in oxygen therapy.
◆ To avoid explosion, DO NOT operate the oxygen monitor in the presence of flammable
anesthetics or in an atmosphere of explosive gases. Operating the oxygen monitor in flam-
mable or explosive atmospheres may result in fire or explosion.
◆ Never allow an excess length of cable near the patient’s head or neck, as such could result in
strangulation. Secure excess cable to the bed rail or suitable object.
◆ Never use a MaxO2 ME+p monitor with a cable that appears worn, cracked or has damaged
insulation.
◆ The oxygen sensors contain a weak acidic solution encapsulated in a plastic housing. Under
normal operating conditions the solution (electrolyte) is never exposed. In case of a leak or if
damaged, DO NOT use the oxygen sensor.
◆ Use only genuine Maxtec accessories and replacement parts. Failure to do so may seriously
impair the monitor’s performance. Repair or alteration of the MaxO2 ME+p beyond the scope
of the maintenance instructions or by anyone other than an authorized Maxtec service
AAMI STD ES60601-1, ISO STD
80601-2-55, IEC STDS 60601-
1-6, 60601-1-8 & 62366
Certified to:
CSA STD C22.2 No. 60601-1
Maxtec LLC
2305 South 1070 West
Salt Lake City, Utah 84119
USA
phone: [phone]
fax: [phone]
email: [e-mail]
web: www.maxtec.com
NOTE: The latest edition of this operating manual can be downloaded from our website at www.maxtec.com
MEE

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person could cause the product to fail to perform as designed. No modification of this equip-
ment allowed.
◆ Calibrate the MaxO2 ME+p weekly when in operation and if environmental conditions change
significantly.(I.e.,Temperature, Humidity, Barometric Pressure. Referto section 2.3 Calibrating the
MaxO2 ME+p Monitor).
◆ UseoftheMaxO2 ME+p neardevicesthatgenerateelectrical fieldsmaycause erratic readings.
◆ If the MaxO2 ME+p is ever exposed to liquids (from spills or immersion) or to any other
physical abuse, turn the instrument OFF, remove batteries and allow to dry completely, then
power ON. This will allow the unit to go through its self test and make sure everything is
operating correctly.
◆ Never autoclave, immerse in liquid or expose the MaxO2ME+p (including sensor) to high
temperatures (>50°C). Never expose the device to liquid, pressure, irradiation vacuum,
steam, or chemicals.
◆ 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.
◆ This device does not contain automatic barometric pressure compensation.
◆ Not for use in an MRI environment.
◆ Battery replacement by inadequately trained personnel could result in a safety hazard.
◆ 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 10.0 Spare Parts and Accessories.
◆ NOTE: The MaxO2 ME+p monitor has been manufactured with a low alarm setting adjustable
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+p with a high pressure air gun. Applying high pressure
air to the MaxO2 ME+p may damage components and render the system inoperable.
DO NOT over clean the MaxO2 ME+p. Repeated use of a cleaning agent can cause residue
buildup on critical components. Excessive residue buildup can affect the MaxO2 ME+p's
performance.
◆ When cleaning the MaxO2 ME+p: DO NOT use harsh abrasives. DO NOT immerse the
MaxO2 ME+p in liquid sterilizing agents or liquids of any kind. DO NOT spray cleaning
solution directly onto the device. DO NOT allow cleaning solution to pool on the device.
DO NOT sterilize the MaxO2 ME+p. Standard sterilization techniques may damage the
monitor.
◆ If the MaxO2 ME+p does not function as outlined in section 2.0, contact a Maxtec trained
service technician or Maxtec for service.
DO NOT disassemble the MaxO2 MaxO2 ME+p. All service should be performed by a Maxtec
Certified Service Technician.
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.
◆ 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+p.
◆ The MaxO2ME+p and sensor are non-sterile devices.
◆ Regularly inspect the MaxO2 ME+p and associated components for damage or electrolyte
leakage prior to use.
DO NOT use if damaged.
DO NOT obstruct alarm.
DO NOT smoke in an area where oxygen is being administered.
◆ The MaxO2 ME+p may only be calibrated using 20.9% oxygen (room air) or 100% oxygen.
Calibration at other concentrations will result in inaccurate readings.
◆ 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.
◆ 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.
◆ To reduce the risk of cross contamination, only single use pressure monitoring line with an
inline filter should be used with this device.
DO NOT allow liquids or debris to enter the pressure monitor port.
◆ Replace the pressure monitoring line if condensation build-up occurs.
◆ In order to reduce the potential issues associated with condensation, the pressure monitor-
ing line connector should be positioned at least 10 inches (25cm) below the monitor.
DO NOT use for pressure in excess of 60 cmH2O.
DO NOT connect pressure monitoring line to patient IV line.
◆ Secure the pressure monitoring line to avoid kinks and unintended disconnects.
◆ Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the European Member State in which the user
and/or patient is established as applicable.

TABLE OF CONTENTS
CLASSIFICATION ....................................................2
WARRANTY .............................................................2
WARNINGS .........................................................2
SYMBOL GUIDE .......................................................5
1.0 SYSTEM OVERVIEW.........................................5
1.1 Base Unit Description..........................................................................................5
1.2 Essential Device Performance...........................................................................6
1.3 Component Identification..................................................................................6
1.4 MAX-550E Oxygen Sensor..................................................................................7
2.0 SETUP PROCEDURE........................................7
2.1 Battery Installation/Replacement.....................................................................7
2.2 Adjusting Alarm and Calibration Modes..........................................................8
2.3 Calibrating the MaxO2ME+p Monitor................................................................8
2.3.1 Before You Begin ..................................................................................8
2.3.2 To Calibrate the MaxO2ME+p Monitor to 20.9% Oxygen...................8
2.3.3 To Calibrate the MaxO2ME+p Monitor to 100% Oxygen (recommend-
ed)....................................................................................................................8
2.3.4 Factors Influencing Oxygen Calibration.............................................8
2.3.5 Zero Calibration....................................................................................9
3.0 OPERATING INSTRUCTIONS .........................9
3.1 Alarm Setting Procedure....................................................................................9
3.1.1 Low Alarm Setting.................................................................................9
3.1.2 High Alarm Setting...............................................................................9
3.1.3 Smart Alarm Mode................................................................................9
3.1.4 Pressure Monitoring and Alarms......................................................10
3.2 Basic Operation ............................................................................................... 10
3.2.1 Pressure Monitoring Operation ........................................................10
3.2.2 Disabling Oxygen Monitoring ..........................................................10
3.3 Alarm Conditions and Priorities.....................................................................10
3.3.1 Multiple Alarms.................................................................................... 11
3.4 Backlight Operation.......................................................................................... 11
3.5 External Power Supply Operation................................................................... 11
4.0 SENSOR REMOVAL AND REPLACEMENT .. 11
5.0 PRESSURE MONITOR TESTS ........................ 11
5.1 Pressure Monitor Accuracy Test........................................................................ 11
5.2 Pressure Monitor Functional Test ...................................................................12
6.0 TROUBLESHOOTING .................................... 12
7.0 CLEANING AND MAINTENANCE................. 12
7.1 Cleaning.............................................................................................................12
7.2 Alarm Testing....................................................................................................13
7.3 Replacing Sensor Cable....................................................................................13
8.0 SPECIFICATIONS ........................................... 13
8.1 Base Unit Specifications...................................................................................13
8.2 Pressure Monitor Specifications .....................................................................13
9.0 APPLICATIONS............................................... 13
9.1 Exposure to Anesthetic Gases .........................................................................13
9.2 Calibration Techniques in Pressurized Systems............................................13
9.3 Calibration Errors .............................................................................................13
10.0 SPARE PARTS AND ACCESSORIES........... 14
11.0 ELECTROMAGNETIC COMPATIBILITY ...... 14

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SYMBOL GUIDE
The following symbols and safety labels are found on the MaxO2 ME+p:
On/O and Mode Key Silent Key Federal law (USA) restricts this device
to sale by or on order of a physician
Calibration/Zero Key Smart Alarm Key
Attention, consult accompanying
documents (blue background
with white pictogram)
Calibration Reminder Low Alarm Indicator Single Use
Unlock Key Alarm Silence Indicator Serial Number
Backlight Key Up (High Alarm) Key Catalog Number
High Alarm Indicator Direct Current Complies with Directive 2011/65/EU
Smart Alarm Mode Indicator Two means of patient protection
(double insulated) Ingress Protection Rating
Down (Low Alarm) Key Regulatory Compliance Mark Combined UL / CSA Mark
Power Supply Indicator Meets ETL Standards Corrosive
Battery Indicator
50°C
(122°F)
-15°C
(5°F) Storage Temperature Range Do not throw away. Follow local
guidlines for disposal.
Manufacturer Date of Manufacture Type B Applied Parts
Warning (yellow background with
black triangle/pictogram) Do Not (red circle/diagonal) Pressure Mode
Caution For use in dry indoor locations Oxygen Mode
MR Unsafe (red circle/diagonal
with black pictogram) Humidity Limitation Power Plug Polarity
Non-DEHP Batch Code Not Manufactured with Natural Rubber Latex
1.0 SYSTEM OVERVIEW
1.1 Base Unit Description
The MaxO2 ME+p is a handheld monitor capable of measuring the oxygen concentration from 0% to
100% and pressure from -15 – 60 cmH2O in a sample gas. This device should only be used by clinically
trained operators with sufficient knowledge, training and understanding of this manual. A MAX-550E
oxygen sensor outputs a voltage which is used by the MaxO2 ME+p to determine the concentration of
oxygen based on a calibration at room air (21% O2) or pure (100% O2) oxygen. The pressure reading
displayed is a 2 second mean pressure, relative to the ambient conditions, ie. referenced to ambient as
0. The monitor provides user adjustable low and high alarm limits which, when exceeded, trigger an
audible and visual alarm. The associated low and high alarm limits are displayed to the left and right of
the readings respectively. The monitor indirectly contacts the patient through the breathing gas path-
way via the MAX-550 Oxygen sensor membrane
•Oxygen sensor of approximately 1,500,000 O2 percent hours.
•External oxygen sensor with 10 ft. extendable cable and diverter fitting for standard 15 mm "T"
adapter.
•Operation using 4 AA alkaline batteries (4 x 1.5 volts) for approximately 5000 hours of
performance with typical use.
•Oxygen-specific, galvanic sensor that achieves 90% of final value in approximately 15 seconds
at room temperature.
•Self-diagnostic check of analog and microprocessor circuitry.
•Battery level indicator.
•Calibration reminder timer that alerts the operator, using a calibration icon on the LCD display,
to perform a unit calibration.
•Adjustable high-level and low-level alarming capability with flashing LED and audible
indication of alarm conditions.
•Smart high-low alarm setting to help adjust alarm settings quickly
•Back-light display with auto ambient light level detection.

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Indication for Use:
The MaxO2ME+p is an oxygen monitor with integrated pressure monitoring intended for con-
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
MaxO2ME+p is not intended as a life-supporting device or life sustaining device.
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
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.
9
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 — This key is used to turn the device on or off. To turn
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cmH2O.
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
(cmH2O).
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 — High alarm symbol used for identifying the high alarm
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 — The calibration reminder symbol is located at the bot-
tom of the display. This symbol will be lighted after one week has elapsed from the
previous oxygen calibration.
f
BATTERY INDICATOR — The battery indicator is located at the bottom of the dis-
play and bars indicate approximate battery level remaining.
g
ALARM SILENCE/SMART ALARM INDICATOR — When the silent key is pressed the
indicator will display with cross bars to alert condition. When Smart Alarm Mode
Button is pressed the indicator will display with T-bars to alert condition.
h
OXYGEN LOW ALARM LIMIT — Low oxygen alarm setpoint. Audible and visual alarms will
trigger when this limit is exceeded.
j
LOW ALARM INDICATOR — Low alarm symbol used for identifying the low alarm
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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1.4 MAX-550E Oxygen Sensor
The MAX-550E is a galvanic, partial pressure sensor that is specific to oxygen. It consists of
two electrodes (a cathode and an anode), a FEP membrane and an electrolyte. Oxygen dif-
fuses through the FEP membrane and immediately reacts electrochemically at a gold cathode.
Concurrently, oxidation occurs electrochemically at a lead anode, generating an electrical cur-
rent and providing a voltage output. Electrodes are immersed in a unique gelled weak acid
electrolyte which is responsible for the sensors long life and motion insensitive characteristic.
Since the sensor is specific to oxygen, the current generated is proportional to the amount of
oxygen present in the sample gas. When no oxygen is present, there is no electrochemical
reaction and therefore, negligible current is produced. In this sense, the sensor is self-zeroing.
CAUTION: The MAX-550E oxygen sensor is a sealed device containing a mild acid electro-
lyte, lead (Pb), and lead acetate. Lead and lead acetate are hazardous waste constituents. Be
sure to dispose of expired sensors in accordance with hospital, local, state, and federal regula-
tions, or return to Maxtec for proper disposal or recovery.
CAUTION: Dropping or severely jarring the sensor after calibration may shift the calibra-
tion point enough to require recalibration.
CAUTION: The flow diverter for the sensor is for use with flowing gases only.
DO NOT use the diverter when performing static sampling, such as in incubators, oxygen
tents, oxygen hoods, etc.
2.0 SETUP PROCEDURE
2.1 Battery Installation/Replacement
All MaxO2 ME+p units are powered by four, AA, alkaline batteries (4 x 1.5 Volts) and are shipped
without the batteries installed. The battery compartment is accessible from the back side of the
unit. Batteries should be changed by qualified service personnel. Use only brand name batter-
ies. Replace with four AA batteries and insert per orientation marked on the device.
When batteries are installed in the MaxO2ME+p, the unit initiates a self diagnostic test. All seg-
ments of the LCD readout are turned on for approximately 2 seconds. The audio buzzer sounds
and the high and low alarm LEDs are illuminated. When the diagnostic test is completed suc-
cessfully, the word "CAL" will display and then automatically initiate a calibration.
WARNING: Battery replacement by inadequately trained personnel could result in a
safety hazard. The MaxO2ME+p will automatically perform a new calibration any time the
batteries are removed or replaced. Ensure that the sensor is exposed to either 20.9% oxygen
(room air) or 100% oxygen when changing the batteries to avoid mis-calibration.
To install the batteries:
1. Release the thumb screw by turning it counter-clockwise until it pops out.
2. Install the four, AA, alkaline batteries (4 x 1.5 Volts) in the unit, observing the
orientation shown on the plastic inside the compartment.
3. Slide the battery compartment cover back onto the case. Press in on the thumb screw
while turning it clockwise until it engages the thread in the enclosure. Turn until it is
lightly tightened. DO NOT over-tighten.
WARNING: 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 Section 10.0 Spare Parts and Accessories.
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.
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BATTERY ICON : The battery bars indicate the approximate remaining power in the
batteries.
Indicator Battery Level
(Outline flashing)
(1 bar flashing)
100%
80%
60%
40%
20%
0%
(Outline flashing + E04)
2.2 Adjusting Alarm and Calibration Modes
You must select oxygen or pressure mode prior to adjusting alarms or performing a
calibration/zero. To set the device mode:
1. Unlock the device by pressing the unlock key.
2. Once unlocked the display will flash and you can toggle either oxygen or
pressure mode by pressing the power/mode key.
3. The respective alarms and calibration may now be performed.
Press unlock key
Press mode key to
select oxygen (O2)
or pressure (P)
Set alarms or
calibrate for
oxygen
Set alarms or
zero for
pressure
P
PRESSURE
O2
OXYGEN
2.3 Calibrating the MaxO2ME+p Monitor
2.3.1 Before You Begin
A protective film covering the threaded sensor face must be removed; wait approximately 20
minutes for the sensor to reach equilibrium.
Next, the MaxO2ME+p monitor should be calibrated. Thereafter, Maxtec recommends calibra-
tion on a weekly basis. However, more frequent calibration will not adversely affect product
performance.
Calibration of the instrument should be performed when the temperature of the gas stream
changes by more than 3 degrees Celsius.
Changes in barometric pressure can affect the oxygen reading. A 1% change in the barometric
pressure results in an error of 1% of actual reading (Example: If you are reading a 50% oxygen
mix and the barometric pressure drops from 1000mbar to 990mbar the reading will drop to:
50% x (990/1000) = 49.5%). Maxtec recommends that you re-calibrate after changing point-
of-use elevation by more than 500 feet (150m).
In addition, calibration is recommended if the user is unsure when the last calibration proce-
dure was performed or if the measurement value displayed is in question.
It is best to calibrate the MaxO2ME+p monitor at a pressure and flow similar to your clinical
application.
NOTE: Before beginning calibration the MAX-550E sensor must be in thermal equilibrium.
You may also need to be aware of other factors which affect device calibration values. For
more information, refer to “Factors Influencing Calibration and Performance” in this manual.
The main display is capable of reading oxygen in the range of 0-105%. This additional range
beyond physically possible concentration is to allow the user to be able to see if the device is
reading accurately by testing in room air or 100% oxygen.
2.3.2 To Calibrate the MaxO2ME+p Monitor
to 20.9% Oxygen
1. Ensure the sensor is in room air and has had sufficient time to equilibrate with room
temperature.
2. Using the ON/OFF key , make sure the unit is powered on.
3. Allow the oxygen reading to stabilize. This will normally take about 30 seconds or
more.
4. Press the Unlock key to unlock the keypad. Note the LOW, Smart Alarm, CAL, and
HIGH icons will begin to flash indicating the SET OPERATING MODE. Verify device is in O2
mode.
5. Press the CALIBRATION key on the keypad. The word "CAL" will appear on the
display for approximately 5 seconds and then finish with 20.9%.
6. The unit is now calibrated and in the normal operating mode.
2.3.3 To Calibrate the MaxO2ME+p Monitor
to 100% Oxygen (recommended)
1. Place the external probe in a stream of medical grade USP or greater than 99% purity
oxygen. Expose the sensor to the calibration gas at a regulated pressure and flow at a
rate of 1-10 liters per minute (2 liters per minute is recommended).
2. Using the ON/OFF key , make sure the unit is in the normal operating mode.
3. Allow the oxygen reading to stabilize. This will normally take about 30 seconds or
more.
4. Press the Unlock key to unlock the keypad. Note the LOW, Smart Alarm, CAL and
HIGH icons will begin to flash indicating the SET OPERATING MODE. Verify device is in O2
mode.
5. Press the CALIBRATION key on the keypad. The word "CAL" will appear on the
display for approximately 5 second and then finish with 100.0%.
6. The unit is now calibrated and in the normal operating mode.
2.3.4 Factors Influencing Oxygen Calibration
The primary factors influencing oxygen measurement on the MaxO2 ME+p monitor are tem-
perature, pressure, and humidity.
Effects of Temperature
The MaxO2ME+p monitor will hold calibration and read correctly within +/-3% when in thermal
equilibrium within the operating temperature range. The device accuracy will be better than
+/-3% if operated at the same temperature at which it was calibrated. The device must be
thermally stable when calibrated and allowed to thermally stabilize after experiencing tem-
peraturechanges before readingis accurate. Forthese reasons, thefollowing is recommended:
1. Allow adequate time for the sensor to equilibrate to a new ambient temperature.
2. When used in a breathing circuit, place the sensor upstream of the heater.
3. For best results, perform the calibration procedure at a temperature close to the
temperature where analysis will occur.

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Pressure Effect
Readings from the MaxO2ME+p monitor are proportional to the partial pressure of oxygen.
The partial pressure of Oxygen (PO2) is equal to the percentage of oxygen (%O2) times the
absolute pressure (AP) at which the sample environment is measured (PO2=%O2 x AP).
Thus the readings are proportional to the concentration if the pressure is held constant. Flow
rate of sample gas can affect pressure at the sensor in that back pressure at the sensing point
may change. For these reasons, the following is recommended:
1. Calibrate the MaxO2ME+p monitor at the same pressure as the sample gas.
2. If sample gases flow through tubing, use the same apparatus and flow rates when
calibrating as when measuring.
Humidity Effect
The MaxO2ME+p monitor can be used in applications where the relative humidity of the sam-
ple gas ranges from 0 to 95%, non-condensing. However, it should be noted that water vapor
exerts its own pressure in the same manner as oxygen does in a sample gas stream.
For example, if the monitor is calibrated in dry gas and then the gas is humidified, the monitor
will correctly display a reading which is slightly lower than previously displayed. This is due to
the dilution of oxygen in the sample gas by water vapor.
This fact is important to note in systems where there exist both “wet” and “dry” gas streams
such as in a ventilator circuit. If the monitor is measuring oxygen on the “dry side” of the ven-
tilator, it will correctly indicate an oxygen concentration slightly greater than actually found in
the “wet side” (delivered to the patient). The water vapor has diluted the gas stream.
Additionally, gas streams of high humidity may tend to condense on the sensor. Condensation
on the sensor may eventually affect performance. For this reason, it is recommended that the
sensor be mounted in a vertical position, facing downward to prevent condensate from flow-
ing onto the sensing surface.
2.3.5 Zero Calibration
A zero calibration resets the zero point of the pressure sensor, the measurement when no
pressure is connected. Perform a zero calibration if the monitor displays a non-zero pressure
reading when no pressure is connected.
To zero the device:
1. Ensure no pressure is connected to the device and open to room air.
2. Unlock the device by pressing the unlock key .
3. Select pressure mode by pressing the power/mode button until is shown on the
display.
4. Press the CAL/0 button. The display will flash '0.0' until the zeroing has been
completed.
5. Verify the pressure display reads 0.0 cmH2O once zeroing is complete.
3.0 OPERATING INSTRUCTIONS
3.1 Alarm Setting Procedure
3.1.1 Low Alarm Setting
To adjust the low alarm setting:
1. Press the Unlock key to unlock the keypad. Note the LOW, Smart Alarm, CAL and
HIGH icons will begin to flash indicating the SET OPERATING MODE.
Select oxygen or pressure by pressing the power/mode key .
2. Press the DOWN (LOW ALARM) key on the keypad.
NOTE: The Low Alarm digits begin to flash indicating the Low Alarm manual setting.
3. Use the UP and DOWN keys to set the low alarm to the desired value.
Pressing the arrow keys changes the value in 1% or 1 cmH2O increments. If the keys are
held down for more than 1 second the display will scroll at a rate of 1% or 1 cmH2O per
second.
NOTE: If 30 seconds elapse between key actuations, the system will store the latest low alarm
value and will revert to normal operation. If this occurs inadvertently, simply repeat the alarm
setting procedure.
There is a special condition that allows the low oxygen alarm to be set below 18%. To access
this condition press the DOWN arrow key for three seconds while the low alarm reading
displays 18%. The alarm setting can now be adjusted to 17, 16, or 15%. A bar will blink above the
setting to provide further indication that the alarm has been set to this special <18% condition.
The low alarm value cannot be set lower than 15%, nor can it be set closer than 1% from the
high alarm value. For example, if the high alarm is set at 25%, the system will not accept a low
alarm setting greater than 24%.
4. When the low alarm value is set, press the Unlock key to accept the low alarm
setting and return to normal operation.
NOTE: The default low alarm setting is 18% O2 and off (––) for pressure. Removing the batter-
ies or shutting the unit OFF will reset the low alarm limit to 18% if it is set to <18%.
3.1.2 High Alarm Setting
To adjust the high alarm setting:
1. Press the Unlock key to unlock the keypad. Note the LOW, SMART ALARM, CAL and
HIGH icons will begin to flash indicating the SET OPERATING MODE.
Select oxygen or pressure by pressing the power/mode key .
2. Press the UP (HIGH ALARM) key on the key pad.
NOTE: The High Alarm digits begin to flash indicating the High Alarm manual setting.
3. Use the UP and DOWN keys to set the high alarm to the desired value.
Pressing the arrow keys changes the value in 1% or 1 cmH2O increments. If the keys are
held down for more than 1 second the display will scroll at a rate of 1% or 1 cmH2O per
second.
NOTE: If 30 seconds elapse between key actuations, the system will store the latest high alarm
setting and will revert to normal operation. If this occurs inadvertently, simply repeat the
alarm setting procedure.
When the high alarm setting is set above 100% or 60 cmH2O the high alarm will indicate two
dashes - -. This special condition turns off or deactivates the high alarm.
4. When the high alarm value is set, press the Unlock key again to accept the high
alarm setting and return to normal operation.
NOTE: The default high alarm setting is 50% oxgyen and 15 cmH2O pressure. Removing the
batteries will reset the high alarm limits to 50% and 15 cmH2O.

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3.1.3 Smart Alarm Mode
NOTE: Smart alarms function as alarm guardrails which simultaneously set the low and high
alarms to ± 3% oxgyen or ± 2 cmH2O of the current oxygen or pressure reading. This range can
be broadened by pressing the up button or narrowed by pressing the down button.
1. Press the unlock key to unlock the keypad. Note the LOW, Smart Alarm, CAL and
HIGH icons will begin to flash indicating the SET OPERATING MODE.
Select oxygen or pressure by pressing the power/mode key .
2. Press the Smart Alarm key on the keypad. Note the LOW digits, Alarm Mode and
HIGH digits begin a slow flash indicating SMART ALARM MODE. The high alarm will now be
set to be equal to the current reading +3% or + 2 cmH₂0 (rounded to the nearest integer).
The low alarm will now be set to be equal to the current reading -3% or - 2 cmH₂0
(rounded to the nearest integer but never lower than 18%).
3. Pressing the Up key will add one to the high alarm setting and subtract one from
the low alarm setting. Pressing the Down key will subtract one from the high
alarm setting and add one to the low alarm setting. In other words, the Up Arrow
widens the alarm band and the down arrow tightens the alarm band. This feature will
not set the alarm levels above 100% or below 18% for oxygen or above 60 cmH2O or
below 1 cmH2O for pressure.
4. Once the desired alarm settings are attained, press the Unlock key to save the
settings and return to normal operation mode. If 30 seconds elapse without a key
press by the user, the device will automatically save the new alarm settings and return
to normal operation mode.
3.1.4 Pressure Monitoring and Alarms
The monitor displays the mean pressure using a 2 second average. Pressure monitoring
begins immediately once the device is powered on. The device will activate an audible and
visual (LED) alarm whenever the alarm limits are exceeded, however the pressure alarms are
delayed by 3 seconds to allow for momentary fluctuations in pressure and reduce unnecessary
alarm disturbances.
By default, the pressure alarms are set to off (--) for the LOW alarm and and 15 cmH2O for the
HIGH alarm. Pressure alarms are automatically saved in the device memory and recalled to the
last settings whenever the device is powered on/off. Alarm default setpoints are only reset by
removing and re-installing the batteries.
3.2 Basic Operation
To check the oxygen concentration of a sample gas:
1. Using the ON/OFF key , make sure the unit is in the power on mode and properly
calibrated.
2. Place the external flow diverter in the sample gas stream. When using a standard
"T" adapter, make sure the sensor is mounted in the adapter with the flow diverter
pointing downward. This will prevent moisture from potentially draining into the
sensor membrane.
NOTE: It is important that a tight fit exists between the diverter and the "T" adapter.
3. Initiate flow of the sample gas to the sensor.
3.2.1 Pressure Monitoring Operation
The monitor measures pressure using pressure monitoring line with moisture control tubing
that includes and inline filter. The filter protects the monitor from moisture and reduces the
risk of cross contamination. The pressure monitoring line and filter is single use and should
always be discarded between patients. When in use on a single patient in an ongoing proce-
dure, it must be discarded and replaced every 30 days or sooner
To begin pressure monitoring:
1. Perform a zero calibration if the monitor displays a non-zero pressure reading. (See
section 2.3.5)
2. Locate the pressure monitor port on the device and push in the connector of pressure
monitoring line until it clicks into place.
9 cm
8 cm
7 cm
6 cm
5 cm
4 cm
3 cm
2 cm
1 cm
0 cm
3. Locate and attach the other end of the pressure monitoring line into the circuit to be
monitored using the Luer connector.
4. Adjust the low and high pressure alarms to the desired range. Alternatively, the
pressure alarms may be set automatically using the smart alarm button.
5. The device will now monitor pressure between the set range.
WARNING: In order to reduce the potential issues associated with condensation in the
pressure monitoring line, the pressure monitoring line connector should be positioned at least
10 inches (25 cm) below the monitor.
WARNING: To reduce the risk of cross contamination, only single use pressure monitoring
line with an inline filter should be used with this device.
WARNING: This product may expose you to chemicals known to the state of California
to cause cancer and/or reproductive harm. For more information, go to www.p65warnings.
ca.gov
DO NOT allow liquids or debris to enter the pressure monitor port.
◆ Replace the pressure monitoring line if condensation build-up occurs.
DO NOT use for pressure in excess of 60 cmH2O.
DO NOT connect pressure monitoring line to patient IV line.
◆ The pressure monitoring line is intended to be used on an individual patient during a single
procedure then disposed of. The pressure monitoring line must be discarded and replaced
between each patient and procedure. When in use on a single patient in an ongoing proce-
dure, it must be discarded and replaced every 30 days or sooner. The pressure monitoring
line is NOT intended to be reprocessed.
3.2.2 Disabling Oxygen Monitoring
The MaxO2 ME+p may be used to monitor pressure only by disabling the oxygen monitor.
The oxygen monitoring function may be disabled by disconnecting the oxygen sensor and
cable. The MaxO2 ME+p will display an E02 error indicating a sensor disconnect. Acknowledge
the error by pressing the alarm silence key. This will clear the error and the display will
read - - -, indicating the oxygen sensor has been removed and no oxygen reading is available.
In this configuration, the MaxO2 ME+p will only monitor pressure in the upper portion of the
display with the associated low and high alarms. The oxygen monitoring function
may be restored by reattaching the oxygen sensor and cable, which will trigger an automatic
calibration of the oxygen sensor.
NOTE: The oxygen sensor disconnect error (E02) will repeat anytime the device is turned off
with the oxygen sensor disconnected.
WARNING: Disconnecting the oxygen sensor will disable all oxygen monitoring functions
and alarms.