Maxtec MaxO2ME User manual

MaxO2 ME
Instructions for Use
ENGLISH
R230M01-001 REV. H

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This manual describes the function, operation and maintenance of the Maxtec Model MaxO2ME
oxygen monitor. The MaxO2ME utilizes the Maxtec Max-550E oxygen sensor and is engineered
for fast response, maximum reliability and stable performance. The MaxO2ME 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 ideal for use in neonatal, anesthesia and respiratory care.
CLASSIFICATION
Protection against electric shock .........................................................................................II, Type B
Protection against water................................................................................................................IPX1
Mode of operation..............................................................................................................Continuous
Sterilization................................................................................................................... See section 6.1
Flammable anesthetic mixture ...................................................................................See section 8.1
Power specification...............................................................7.5V(MAX) 1.9W.250mA(MAX)
Product Disposal Instructions:
The sensor, batteries, and circuit board are not suitable for regular trash dis-
posal. Return sensor to Maxtec for proper disposal or dispose according to local
guidelines. Follow local guidelines for disposal of other components. There are
no special considerations for the disposal of the product packaging.
WARRANTY
The MaxO2ME Monitor is designed for medical oxygen delivery equipment and systems.
Under normal operating conditions, Maxtec warrants the MaxO2ME Monitor to be free from
defects of workmanship or materials for a period of two (2) years from the date of receipt
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 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 unit. Should a sensor fail prematurely, the replacement sensor
is warranted for the remainder of the original sensor warranty period. Routine maintenance
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 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 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.
WARNINGS
Indicates a potentially hazardous situation which, if not avoided, could result in death or seri-
ous injury.
◆ Before use, all individuals who will be using the MaxO2ME must become thoroughly familiar with
the information contained in this Operation Manual. Strict adherence to the operating instruc-
tions 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 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 beyond the scope of the
maintenance instructions or by anyone other than an authorized Maxtec service person could
cause the product to fail to perform as designed. No modification of this equipment allowed.
◆ Calibrate the MaxO2ME weekly when in operation and if environmental conditions change
significantly. (I.e., Temperature, Humidity, Barometric Pressure. Refer to section 2.2
Calibration of this manual).
◆ Use of the MaxO2ME near devices that generate electrical fields may cause erratic readings.
◆ If the MaxO2ME 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.
Conforms to:
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
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
EN Instructions for Use

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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.
◆ 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 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.
◆ 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.
◆ 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.
◆ 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.
◆ The MaxO2ME and sensor are non-sterile devices.
◆ 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.
◆ 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.
◆ 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.
◆ 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

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TABLE OF CONTENTS
CLASSIFICATION ....................................................2
WARRANTY .............................................................2
WARNINGS .........................................................2
SYMBOL GUIDE .......................................................3
1.0 SYSTEM OVERVIEW.........................................5
1.1 Base Unit Description..........................................................................................5
1.2 Essential Device Performance...........................................................................5
1.3 Component Identification..................................................................................5
1.4 Max-550E Oxygen Sensor..................................................................................6
2.0 SETUP PROCEDURE........................................6
2.1 Battery Installation/Replacement.....................................................................6
2.2 Calibrating the MaxO2ME Monitor ...................................................................6
2.2.1 Before You Begin ..................................................................................6
2.2.2 To Calibrate the MaxO2ME Monitor to 20.9% Oxygen ......................7
2.2.3 To Calibrate the MaxO2ME Monitor to 100% Oxygen (recommend-
ed)....................................................................................................................7
2.2.4 Factors Influencing Oxygen Calibration.............................................7
3.0 OPERATING INSTRUCTIONS .........................7
3.1 Alarm Setting Procedure....................................................................................7
3.1.1 Low Alarm Setting.................................................................................7
3.1.2 High Alarm Setting...............................................................................8
3.1.3 Smart Alarm Mode................................................................................8
3.2 Basic Operation ..................................................................................................8
3.3 Alarm Conditions and Priorities........................................................................8
3.4 Backlight Operation...........................................................................................9
3.5 Sleep Mode Operation.......................................................................................9
3.6 External Power Supply Operation....................................................................9
4.0 SENSOR REMOVAL AND REPLACEMENT ...9
5.0 PROBLEM SOLVING ........................................9
6.0 CLEANING AND MAINTENANCE ..................9
6.1 Cleaning............................................................................................................ 10
6.2 Alarm Testing..................................................................................................10
6.3 Replacing Sensor Cable..................................................................................10
7.0 SPECIFICATIONS............................................10
7.1 Base Unit Specifications...................................................................................10
8.0 APPLICATIONS...............................................10
8.1 Exposure to Anesthetic Gases ........................................................................ 10
8.2 Calibration Techniques in Pressurized Systems...........................................10
8.3 Calibration Errors .............................................................................................. 11
9.0 SPARE PARTS AND ACCESSORIES ............. 11
10.0 ELECTROMAGNETIC COMPATIBILITY ...... 11

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1.0 SYSTEM OVERVIEW
1.1 Base Unit Description
The MaxO2ME is a handheld oxygen analyzer/monitor capable of measuring the oxygen con-
centration from 0% to 100% in a sample gas. A Max-550E oxygen sensor outputs a voltage
which is used by the MaxO2ME to determine the concentration of oxygen based on a calibra-
tion at room air or 100% oxygen. The MaxO2ME contains alarms that can be controlled by the
user to set a maximum or minimum allowable oxygen concentration.
•Oxygen sensor of approximately 1,500,000 O2 percent hours.
•External probe 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.
•Low battery indication.
•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.
•Sleep Mode operation to extend battery life.
Indication for Use:
The MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of
oxygen being delivered to patients ranging from newborns to adults.
It can be used in the hospital and sub-acute settings. The MaxO2ME is not a life supporting
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
•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
COILED CABLE — The coiled cable allows the sensor to be positioned up to 8 feet from the
side of the unit.
4
OXYGEN SENSOR WITH DIVERTER — The sensor (with diverter) is designed to fit industry
standard, 15mm I.D. "T" adapters.
5
CALIBRATION KEY — This key is used to calibrate the device. The device must be in
the unlocked state for the key to operate. See section 2.2 for instructions on calibrating.
6
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.
7
UNLOCK KEY — The unlock key is used to unlock and lock the instrument.
8
BACKLIGHT — The backlight key will manually activate the backlight for 30 sec-
onds. See section 3.4 for more information on backlighting operation.
9
ALARM SILENCE KEY — In an alarm condition, pressing the SILENT key will deacti-
vate the audible alarm for 2 minutes.
q
ON/OFF 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.
w
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.
e
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%.
r
EXTERNAL POWER SUPPLY PORT — The port provides connection for the external power
supply. See section 3.6 for more information on the power adapter.
t
LCD DISPLAY — The liquid crystal display (LCD) provides direct readout of oxygen con-
centrations. The digits also display error codes, alarm set modes and calibration codes
as necessary.
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OXYGEN CONCENTRATION — Current oxygen concentration percentage from the oxygen
sensor.
u
HIGH ALARM INDICATOR — High alarm symbol used for identifying the high alarm
setpoints and when a high alarm is triggered.
i
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.
o
CALIBRATION REMINDER — The calibration reminder symbol is located at the
bottom of the display. This symbol will be lighted after one week has elapsed from the
previous calibration.
p
SLEEP MODE INDICATOR — The sleep mode Indicator is used to reduce battery con-
sumption. See section 3.5 Sleep Mode Operation.
a
LOW BATTERY INDICATOR — The low battery indicator is located at the bottom
of the display and is only activated when the voltage on the batteries are below a nor-
mal operating level and need to be replaced.
s
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.
d
OXYGEN LOW ALARM LIMIT — Low oxygen alarm setpoint. Audible and visual alarms will
trigger when this limit is exceeded.
f
LOW ALARM INDICATOR — Low alarm symbol used for identifying the low alarm
setpoints and when a low alarm is triggered.
g
<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.
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 and
should be disposed of properly, or returned 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 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
batteries. Replace with four AA batteries and insert per orientation marked on the device.
When batteries are installed in the MaxO2ME, 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 MaxO2ME will automatically perform a new calibration any time the bat-
teries 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 9.0 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.
2.2 Calibrating the MaxO2ME Monitor
2.2.1 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 MaxO2ME 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
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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 MaxO2ME 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.
2.2.2 To Calibrate the MaxO2ME 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.
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.
2.2.3 To Calibrate the MaxO2ME 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.
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.
2.2.4 Factors Influencing Oxygen
Calibration
The primary factors influencing oxygen measurement on the MaxO2ME monitor are tempera-
ture, pressure, and humidity.
Effects of Temperature
The MaxO2ME 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-
peraturechangesbeforereading is accurate. For these reasons, the following 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.
Pressure Effect
Readings from the MaxO2ME 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 abso-
lute 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 MaxO2ME 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 MaxO2ME monitor can be used in applications where the relative humidity of the sample
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.
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.
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% increments. If the keys are held down
for more than 1 second the display will scroll at a rate of 1% 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.

ENGLISH 8WWW.MAXTEC.COM • [phone]
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. Removing the batteries 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.
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% increments. If the keys are held down
for more than 1 second the display will scroll at a rate of 1% 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% 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. Removing the batteries will reset the high
alarm limit to 50%.
3.1.3 Smart Alarm Mode
NOTE: Smart alarms function as alarm guardrails which simultaneously set the low and high
alarms to ± 3% oxgyen of the current 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.
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% (rounded to the nearest interger).
The low alarm will now be set to be equal to the current reading -3% (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.
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.
3.2 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.
3.3 Alarm Conditions and Priorities
In the event of either a low alarm or high alarm condition, the corresponding LED will begin
to flash, accompanied by the audio buzzer. Pressing the SILENT key will deactivate the
buzzer but the LED and the alarm value digits on the display will continue to flash until the
alarm condition has been rectified. If the alarm condition still exists 120 seconds after silencing
the audio buzzer, the beeper will start to sound again.
A low alarm condition will remain until the actual concentration is 0.1% higher than the low
alarm setting. A high alarm condition will remain until the the actual concentration is 0.1%
lower than the high alarm setting.
To help differentiate the levelofpriority,the monitor provides threeunique audible sequences.
ALARM ALARM
PRIORITY
LOW
ALARM
LED
HIGH
ALARM
LED
AUDIBLE
ALARM
AUDIBLE
ALARM
REPEAT
Line Power
Plugged In Informational O O 2 Pulses No Repeat
Line Power
Unplugged Informational Single Yel- low Pulse
Single Yellow
Pulse 2 Pulses No Repeat
External DC
Power Supply
Voltage Out of
Range
Informational Solid Yellow Solid Yellow 2 Pulses Every 15 Sec.
Battery Voltage
too low for
device to operate
(E04)
Medium Pulsing
Yellow
Pulsing
Yellow 3 Pulses Every 25 Sec.
Oxygen level
above the high
alarm setting
Medium O Pulsing
Yellow 3 Pulses Every 25 Sec.
Oxygen level
below the low
alarm setting
Medium Pulsing
Yellow O 3 Pulses Every 25 Sec.
Oxygen level
below the low
oxygen alarm
setting and lower
than 18%
High Pulsing Red O 5+5 Pulses Every 15 Sec.

WWW.MAXTEC.COM • [phone] 9ENGLISH
3.4 Backlight Operation
To turn on the backlighting:
1. When the unit is on, pressing the Backlight key will turn the backlighting on for
30 seconds. Additional presses will turn off the backlighting.
2. If the device is being used in a dark location, press any key to activate the back light.
CAUTION: Excessive use of the backlight can reduce the life of the batteries.
3.5 Sleep Mode Operation
To use the sleep mode function:
1. Remove the batteries from the unit.
2. Locate the sleep mode switch in the battery compartment and set to the ON position.
3. Replace the batteries in the unit.
The unit will now perform a normal boot-up operation with sleep mode enabled. With sleep
mode enabled the unit will function with all the same parameters as outlined above with one
new feature. While in the ON mode, the unit will time-out after 90 seconds to a battery saving
condition. This condition will be indicated by a crescent moon on the display. While in this
condition any key that is pressed will return the unit to the ON mode and reset the 90 second
time-out counter. In sleep mode, the device will continue to monitor the oxygen level and will
activate the alarm if an alarm condition occurs.
3.6 External Power Supply Operation
To extend the life of the batteries a Maxtec approved external power supply can be purchased.
Once connected to the unit, total power is supplied by the external power supply. The batter-
ies are still required to be in the unit and will provide emergency power in the event main AC
power is lost.
NOTE: Use only the Maxtec approved external power supply in Section 9.0 Spare Parts and
Accessories.
NOTE: The power supply is not a battery charger. DO NOT use rechargeable batteries.
WARNING: Do not position the equipment in a way that it would be difficult to unplug the
power supply. Unplugging the power supply is the only means of disconnecting or isolating
the equipment from AC mains power.
4.0 SENSOR REMOVAL AND
REPLACEMENT
The MaxO2ME is shipped with a new Max 550E oxygen sensor.
Although the sensor has a very long expected life, eventually the sensor will require replace-
ment. Removing or installing a sensor, when necessary, is a very simple procedure.
To remove and install a new sensor:
1. Grasp the sensor in one hand and, with the other hand, unscrew the cable connector
counter-clockwise at the sensor.
2. Pull out the cable connector plug from the expired sensor.
3. Unscrew the flow diverter from the sensor and discard the expired sensor or return it
to Maxtec for proper disposal.
NOTE: The sensor contains lead and lead acetate, be sure to dispose of expired sensors in
accordance with hospital, local, state and federal regulations.
4. Remove the new sensor from the packaging and remove the protective film from the
sensor face.
5. Insert the cable connector plug into the receptacle of the new sensor and tighten the
cable connector.
6. Screw the flow diverter onto the new sensor.
7. Wait approximately 20 minutes for the sensor to reach equilibrium.
8. Calibrate the new sensor.
NOTE: If the monitor is on when the sensor is detached and replaced, the monitor will auto-
matically force a re-calibration. The display will read “CAL”.
NOTE: If the cable locking nut is not fully fastened onto the sensor, then the sensor may not
function properly.
5.0 PROBLEM SOLVING
The MaxO2ME monitors have a self test feature built into the software to detect faulty calibra-
tions, oxygen sensor failures, and low operating voltage. These are listed below, and include
possible actions to take, if an error code occurs.
NOTE: The operator must be facing the device and positioned within 4 meters to distinguish
the visual alarm indicators. Audible alarms can be distinguished as long as the operator is in
the same room and the ambient noise level is typical for a clinical setting.
LOW BATTERY ICON :If the low battery icon is displayed on the LCD readout at any time,
the batteries should be replaced as quickly as possible.
E01: Calibration error, sensor output lower than expected. See note below.
E02: No sensor attached. Reconnect sensor, see note below.
E03: No Valid Calibration Data Available, make sure unit has reached thermal equilibrium and
perform a calibration routine.
E04: Battery Below Minimum Operating Voltage, replace batteries. A medium priority alarm will
sound every 25 seconds until the batteries are replaced or become too dead to sound the alarm.
E05: Calibration error, sensor output higher than expected. See note below.
E06: Non-compatible oxygen sensor. Reconnect sensor, see note below.
E07: Calibration error, sensor output is not stable. See note below.
E08: Calibration error, battery too low to preform calibration. Replace batteries and
re-calibrate.
NOTE: If you receive a E01, E05, or an E07 error code, correct by ensuring the calibration gas is
either room air or 100% oxygen. Also ensure the calibration gas flow, pressure and concentra-
tion is constant. Allow sufficient time for the sensor to stabilize in the calibration gas and with
room temperature, then attempt to calibrate again.
If these steps do not correct the error, contact Maxtec for technical support.
NOTE: Use only a Maxtec approved Max-550E sensor called out in Section 9.0 Spare Parts and
Accessories. The Max 550E sensor is equipped with an authentication chip to ensure the moni-
tor is used with an approved sensor.
NOTE: Correcting E02 or E06 errors:
1. Disconnect the sensor and reconnect, making sure the male plug is fully inserted into
the receptacle before tightening the threaded locking shroud. The analyzer should now
perform a new calibration with the error cleared.
2. If the error still persists, remove the batteries and external power, wait 30 seconds,
then reinstall to perform a factory reset and diagnostic on the analyzer. The analyzer
should again perform a new calibration with the error cleared.
3. Contact Maxtec Customer Service Department if the error code cannot be cleared.

ENGLISH 10 WWW.MAXTEC.COM • [phone]
6.0 CLEANING AND MAINTENANCE
6.1 Cleaning
The external surfaces of the device and its accessories can be cleaned and disinfected using the
process detailed below. Under normal use conditions, the surfaces of the sensor and T-adapter
/ flow diverter that come in contact with gas delivered to the patient should not become
contaminated. If you suspect that the sensing face of the sensor or internal surfaces of the
T-adapter / flow diverter have become contaminated, these items should be discarded and
replaced. Store the MaxOME in a clean, dry location when not in use.
1. The MaxO2 ME needs to be cleaned between each patient's use.
2. Using Super Sani-Cloth germicidal disposable wipes (medical grade 2-in-1 cleaning /
disinfecting wipes) remove all visible contamination from the external surfaces of the
device and its accessories. Be sure to closely inspect and remove contamination from
seams and recesses on the device that may trap contaminants.
3. After all visible contamination is removed, use a second germicidal wipe to thoroughly
wet the surfaces of the device and accessories. Allow to remain wet for 4 minutes. Use
additional wipes if needed to assure surfaces are wetted continuously for 4 minutes.
4. Allow device to air dry.
5. Visually inspect each component for visible contamination.
CAUTION: Excessive rubbing of labels may cause them to become illegible.
DO NOT spray cleaning solutions directly onto the monitor, sensor or buzzer opening.
DO NOT immerse the MaxO2ME or sensor into liquid decontamination agents.
DO NOT use strong solvent cleaners.
DO NOT allow cleaning liquids to contact the face of the sensor as this may impair the
readings of the sensor.
DO NOT attempt to sterilize the MaxO2ME with steam, ethylene oxide or irradiation.
6.2 Alarm Testing
Periodic testing of alarms should be performed on a yearly basis.
To check the low alarm, adjust the low alarm setting to 23% or higher and expose the sensor to
room air (20.9%). The low alarm LED should flash with the alarm sound.
To check the high alarm, adjust the low alarm setting to 17% or lower and the high alarm
setting to 18% and expose the sensor to room air (20.9%). The high alarm LED should flash
with the alarm sound. If one or both alarms malfunction, contact Maxtec Certified Service
Technician.
6.3 Replacing Sensor Cable
After extended use or abuse to the sensor cable, the cable may begin to wear and lose its
ability to properly retract.
The cable can be removed and replaced by disconnecting the threaded locking shroud at the
sensor and monitor ends of the cable. Use only the Maxtec approved cable called out in Section
9.0 Spare Parts and Accessories.
NOTE: Ensure the cable locking shroud is fully threaded on the sensor and the monitor.
7.0 SPECIFICATIONS
7.1 Base Unit Specifications
Measurement Range............................................................................................................. 0.0-100%
Resolution.......................................................................................................................................0.1%
Accuracy and Linearity .......................................... ±1% of full scale at constant temperature, R.H.
and pressure when calibrated at full scale
Total Accuracy...........................±3% Actual oxygen level over full operating temperature range
Response Time .........................................90% of final value in approximately 15 seconds at 23°C
Warm-up Time............................................................................................................. none required
Operating Temperature............................................................................. 15°C - 40°C (59°F - 104°F)
Storage Temperature.................................................................................. -15°C - 50°C (5°F - 122°F)
Atmospheric Pressure................................................................................................ 800-1013 mBars
Humidity .....................................................................................................0-95% (non-condensing)
Power Requirements............................................................ 4, AA Alkaline batteries (4 X 1.5 Volts)
Battery Life........................................................................approximately 5000 hours in typical use
Low Battery Indication ................................................................ "LOW BAT" icon displayed on LCD
Sensor Type................................................................................ Maxtec Max-550E galvanic fuel cell
Expected Sensor Life......................... >1,500,000% O2 Hours over 2 years in typical applications
Alarm System.............................................................. high/low alarms, flashing red/yellow LEDs,
nominal 975Hz audio buzzer
(according to IEC 60601-1-8 Audible Alarms in Medical Equipment)
Alarm Volume (all priorities).............................................................. 70 dB(A) ± 7 dB(A) at 1 meter
Low Oxygen Alarm Range....................................................15%-99% (>1% lower than high alarm)
High Oxygen Alarm Range................................................ 16%-100% (>1% higher than low alarm)
Alarm Accuracy................................................................................ exact to displayed alarm value
Dimensions ..................................................3.6"(W) x 5.8"(H) x 1.2"(D) [91mm x 147mm x 30mm]
Weight............................................................................................ approximately 0.89 lbs. (.40 kg)
Cable Length............................................................................................... 9 ft. (3m) fully extended
Diverter Fitting ...............................................................fits industry standard, 15 mm "T" adapter
8.0 APPLICATIONS
8.1 Exposure to Anesthetic Gases
Because of the unique chemistry of the oxygen sensors provided with the MaxO2ME monitor,
there are no significant effects when exposed to commonly used anesthetic gases, however,
the monitor is not designed for exposure to flammable gas mixtures (See WARNING page
2).
INTERFERENT VOLUME % DRY INTERFERENCE IN O2%
Nitrous Oxide 60% balance O2 <1.5%
Halothane 4% <1.5%
Enflurane 5% <1.5%
Isoflurane 5% <1.5%
Helium 50%, balance O2 <1.5%
Sevoflurane 5% <1.5%
Desflurane 15% <1.5%
NOTE: Balance mixture 30% O2/70%N2O, unless otherwise specified.
8.2 Calibration Techniques in Pressurized
Systems

WWW.MAXTEC.COM • [phone] 11 ENGLISH
Similar to other oxygen sensors, the Maxtec MAX series sensors measure the partial pressure
of oxygen in a gas stream. This is correlated to read “percent oxygen” on the MaxO2ME moni-
tor. It is important to note that the sensor output is directly proportional to the partial pressure
of oxygen. Thus, one must take into consideration the effect of exposing the sensor to various
gas sample pressures.
For example, if a monitor is calibrated to read 20.9% in ambient air (atmospheric pressure) and
then exposed to a pressurized gas sample containing a known concentration of oxygen, the
monitor will display a reading greater than the actual oxygen percentage.
This is because the monitor was originally calibrated at atmospheric pressure (0 PSIG) then
exposed to a higher pressure sample (i.e., 5 PSIG).
The greater the difference in pressure, the greater the difference in sensor signal (oxygen
reading on the monitor).
If a monitor is calibrated on a pressurized gas sample containing a known concentration of
oxygen and then exposed to ambient air (atmospheric pressure), the monitor will display a
reading less than the actual oxygen percentage.To avoid confusion, the monitor can be cali-
brated at a single point on a gas stream similar to the application. If, for example, the purpose
of the monitor is to measure oxygen in a concentrator or anesthesia application, the optimal
results may be attained by calibrating the instrument on a gas of similar concentration and
pressure. This would typically be done by connecting to a cylinder of a known high concentra-
tion of oxygen calibration gas and adjusting the flow and pressure to match the application
before calibrating the instrument.
8.3 Calibration Errors
The MaxO2ME monitor has a self test feature built into the software to detect faulty cali-
brations. During calibration, if the signal from the oxygen sensor is outside the limits stored
within the instrument’s memory, a flashing E01 or E05 error code is displayed. The error code
is displayed to indicate that either the sensor should be replaced or that there is a fault in the
calibration process. A few simple hints can prevent calibration errors. If you try to calibrate the
monitor before the reading has stabilized, the E01 or E05 error code may appear. For example,
if the monitor had just been calibrated on a known high concentration of oxygen source gas
and then exposed to ambient air, you should wait until the reading has stabilized.
If you try to calibrate in room air before the sample line has cleared, the sensor may actually
be exposed to residual oxygen. The signal from the sensor would still be high and considered
out of range for air, thus resulting in an E05 or E07 error code. The proper procedure is to wait
for the reading to stabilize before calibration.
Also note that the monitor may sense that the concentration is changing and an E07 error
code will display.
Sensors come supplied with a flow diverter. The flow diverter helps direct the gas in a
T-adapter up to the sensor for analysis. The flow diverter should be only used with a flowing
gas. When using the sensor in a non-flowing environment, remove the diverter tip.
9.0 SPARE PARTS AND ACCESSORIES
PART NUMBER ITEM
R140P02 Max-550E Sensor
R228P87 Battery Cover
R228P16 Sensor Cable
R228P10 Kickstand
R230M01 MaxO2ME Operation Manual
R207P17 Barbed Concentrator Adapter for Sensor
PART NUMBER ITEM
R205P86 Monitor/Analyzer Wall Mount Bracket
R206P75 Monitor/Analyzer Pole Mount Clamp
RP16P02 Maxtec Approved Tee Adapter (15mm I.D.)
R110P10-001 Sensor Flow Diverter
R230P10 Maxtec Approved External Power Supply
Repair of this equipment must be performed by a Maxtec Certified Service Technician experi-
enced in repair of portable hand held medical equipment.
Equipment in need of repair should be sent to:
Maxtec
Service Department
2305 South 1070 West
Salt Lake City, Ut 84119
1.800.748.5355
(Include RMA number issued by Customer Service)
10.0 ELECTROMAGNETIC
COMPATIBILITY
The information contained in this section (such as separation distances) is in general specifi-
cally written with regard to the MaxOME monitor. The numbers provided will not guarantee
faultless operation but should provide reasonable assurance of such. This information may
not be applicable to other medical electrical equipment; older equipment may be particularly
susceptible to interference.
Note: Medical electrical equipment requires special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to the EMC infor-
mation provided in this document and the remainder of the instructions for use this device.
Portable and mobile RF communications equipment can affect medical electrical equipment.
Cables and accessories not specified within the instructions for use are not authorized. Using
other cables and/or accessories may adversely impact safety, performance and electromag-
netic compatibility (increased emission and decreased immunity).
Care should be taken if the equipment is used adjacent to or stacked with other equipment;
if adjacent or stacked use is inevitable, the equipment should be observed to verify normal
operation in the configuration in which it will be used.
ELECTROMAGNETIC EMISSIONS
This equipment is intended for use in the electromagnetic environment specified below.
The user of this equipment should assure that it is used in such an environment.
EMISSIONS COMPLIANCE
ACCORDING TO ELECTROMAGNETIC ENVIRONMENT
RF Emissions
(CISPR 11)
Group 1 The MaxOME uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.

ENGLISH 12 WWW.MAXTEC.COM • [phone]
CISPR Emissions
Classification
Class A The MaxOME is suitable for use in all
establishments other than domestic and
those directly connected to the public low-
voltage power supply network that supplies
buildings used for domestic purposes.
NOTE: The EMISSIONS characteristics of this
equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used
in a residential environment (for which CISPR
11 class B is normally required) this equipment
might not oer adequate protection to radio-
frequency communication services. The user
might need to take mitigation measures, such
as relocating or re-orienting the equipment.
Harmonic Emissions
(IEC 61000-3-2)
Class A
Voltage Fluctuations Complies
ELECTROMAGNETIC IMMUNITY
This equipment is intended for use in the electromagnetic environment specified below.
The user of this equipment should assure that it is used in such an environment.
IMMUNITY
AGAINST
IEC 60601-1-2: (4TH EDITION)
TEST LEVEL
ELECTROMAGNETIC
ENVIRONMENT
Professional
Healthcare Facility
Environment
Home
Healthcare
Environment
Electrostatic
discharge, ESD
(IEC 61000-4-2)
Contact discharge: ±8 kV
Air discharge: ±2 kV, ±4 kV, ±8 kV, ±15 kV
Floors should be wood,
concrete, or ceramic
tile. If floors are covered
with synthetic material,
the relative humidity
should be kept at levels
to reduce electrostatic
charge to suitable levels.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Equipment which emits
high levels of power
line magnetic fields (in
excess of 30A/m) should
be kept at a distance to
reduce the likelihood of
interference.
If user requires
continued operation
during power mains
interruptions,
ensure that batteries
are installed and
charged. Ensure that
battery life exceeds
longest anticipated
power outages or
provide an additional
uninterruptible
power source.
Electrical fast
transients / bursts
(IEC 61000-4-5)
Power supply lines: ±2 kV
Longer input / output lines: ±1 kV
Surges on AC mains
lines (IEC 61000-4-5)
Common mode: ±2 kV
Diferential mode: ±1 kV
3 A/m power
frequency magnetic
field 50/60 Hz
(IEC 61000-4-8)
30 A/m
50 Hz or 60 Hz
Voltage dips and
short interruptions
on AC mains input
lines (IEC 61000-4-11)
Dip>95%, 0.5 periods
Dip 60%, 5 periods
Dip 30%, 25 periods
Dip >95%, 5 seconds
Recommended separation distances between portable and mobile
RF communications equipment and the equipment
RATED MAXIMUM
OUTPUT POWER
OF TRANSMITTER
W
Separation distance according to frequency
of transmitters in meters
150 kHz to 80 MHz
d=1.2/V1] √P
80 MHz to 800 MHz
d=1.2/V1] √P
800MHz to 2.5 GHz
d=2.3 √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance
for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propogation
is aected by absorption and reflection from structures, objects, and people.
This equipment is intended for use in the electromagnetic environment
specified below. The customer or the user of this equipment
should assure that it is used in such an environment.
IMMUNITY
TEST
IEC 60601-1-2: 2014 (4TH
EDITION) TEST LEVEL
ELECTROMAGNETIC ENVIRON-
MENT - GUIDANCE
Professional
Healthcare
Facility
Environment
Home Healthcare
Environment
Conducted
RF coupled
into lines (IEC
61000-4-6)
3V (0.15 - 80
MHz)
6V (ISM bands)
3V (0.15 - 80 MHz)
6V (ISM &
Amateur bands)
Portable and mobile RF communications
equipment (including cables) should
be used no closer to any part of the
recommended separation distance calculated
from the equation applicable to the
frequency of the transmitter as below.
Recommended sparation distance:
d=1.2 √P
d=1.2 √P 80 MHz to 800 MHz
d=2.3 √P 800 MHz to 2.7 GHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey a, should be less than the compliance
level in each frequency range b.
Interference may occur in the vicinity of
equipment marked with the following symbol:
Radiated RF
immunity
(IEC
61000-4-3)
3 V/m
80 MHz - 2.7 GHz
80% @ 1 KHz
AM Modulation
10 V/m
80 MHz - 2.7 GHz
80% @ 1 KHz
AM Modulation

WWW.MAXTEC.COM • [phone] 13 ENGLISH
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz
to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) tele-
phones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the mea-
sured field strength in the location in which the equipment is used exceeds the applicable
RF compliance level above, the equipment should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorient-
ing or relocating the equipment.

2305 South 1070 West
Salt Lake City, Utah 84119
[phone]
www.maxtec.com