maxtec Max O2 ME Oxygen Analyzers Instructions
- June 7, 2024
- maxtec
Table of Contents
Max O2 ME Oxygen Analyzers
MaxO2 ME
Instructions for Use
ENGLISH
R230M01-001 REV. H
Maxtec 2305 South 1070 West Salt Lake City, Utah 84119 USA
phone: (800) 748.5355 fax: (801) 973.6090 email: sales@maxtec.com web: www.maxtec.com
NOTE: The latest edition of this operating manual can be downloaded from our website at www.maxtec.com
Conforms to: AAMI STD ES60601-1, ISO STD 80601-2-55, IEC STDS 606011-6,
60601-1-8 & 62366
Certified to: CSA STD C22.2 No. 60601-1
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 disposal. 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 obligation
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 electromagnetic 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 serious 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 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 prescribed 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 flammable 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.
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Never autoclave, immerse in liquid or expose the MaxO2 ME (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 9.0 Spare Parts and Accessories.
NOTE: The MaxO2 ME oxygen 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 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 solution 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 contact with infectious agents.
Gas leaks that cause room air to mix with the gas sample may cause inaccurate
oxygen readings. 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 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 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
Consult Instructions For Use
On/Off Key Calibration Key
Do Not Unlock Key
Calibration Reminder Silent Key
Backlight Key High Alarm Indicator
Smart Alarm Key Low Alarm Indicator
Smart Alarm Mode Indicator
Alarm Silence Indicator
Down (Low Alarm) Key
Up (High Alarm) Key
Low Battery Indicator
Federal law (USA) restricts this device to sale by or on order of a physician
Manufacturer
Sleep Mode Indicator Meets ETL Standards 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
5°C (41°F)
50°C (122°F)
Storage Temperature
Range
Serial Number
Complies with Directive 2011/65/EU
Catalog Number 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
1.0SYSTEM OVERVIEW…………………………………..5 1.1Base Unit
Description………………………………………………………………………………5 1.2Essential Device
Performance…………………………………………………………………5 1.3Component
Identification……………………………………………………………………….5 1.4Max-550E Oxygen Sensor
……………………………………………………………………….6
2.0SETUP PROCEDURE………………………………….6 2.1Battery
Installation/Replacement……………………………………………………………6 2.2Calibrating the MaxO2 ME
Monitor ………………………………………………………….6 2.2.1Before You Begin
……………………………………………………………………….6 2.2.2To Calibrate the MaxO2 ME Monitor to 20.9%
Oxygen …………………. 7 2.2.3To Calibrate the MaxO2 ME Monitor to 100% Oxygen
(recommended)…………………………………………………………………………………………………….. 7 2.2.4Factors
Influencing Oxygen Calibration……………………………………… 7
3.0OPERATING INSTRUCTIONS …………………….7 3.1Alarm Setting
Procedure………………………………………………………………………… 7 3.1.1Low Alarm
Setting……………………………………………………………………… 7 3.1.2High Alarm Setting
…………………………………………………………………….8 3.1.3Smart Alarm
Mode……………………………………………………………………..8 3.2Basic Operation
……………………………………………………………………………………..8 3.3Alarm Conditions and
Priorities………………………………………………………………8 3.4Backlight
Operation……………………………………………………………………………….9 3.5Sleep Mode Operation
……………………………………………………………………………9 3.6External Power Supply
Operation…………………………………………………………..9
4.0SENSOR REMOVAL AND REPLACEMENT …9
5.0PROBLEM SOLVING ………………………………….9
6.0CLEANING AND MAINTENANCE ………………9
6.1Cleaning……………………………………………………………………………………………… 10 6.2Alarm
Testing…………………………………………………………………………………….. 10 6.3Replacing Sensor
Cable………………………………………………………………………. 10
7.0SPECIFICATIONS…………………………………….. 10 7.1Base Unit
Specifications……………………………………………………………………….. 10
8.0APPLICATIONS……………………………………….. 10 8.1Exposure to Anesthetic Gases
……………………………………………………………… 10 8.2Calibration Techniques in Pressurized Systems
……………………………………. 10 8.3Calibration Errors …………………………………………………………………………………. 11
9.0SPARE PARTS AND ACCESSORIES …………. 11
10.0ELECTROMAGNETIC COMPATIBILITY …… 11
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1.0SYSTEM OVERVIEW
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1.1Base 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.
r
· Oxygen sensor of approximately 1,500,000 O2 percent hours.
t
· External probe with 10 ft., extendable cable and diverter fitting for standard 15 mm “T”
adapter.
e · Operation using 4 AA alkaline batteries (4 x 1.5 volts) for approximately 5000 hours of performance with typical use.
5
w · Oxygen-specific, galvanic sensor that achieves 90% of final value in approximately 15
6
seconds at room temperature.
· Self-diagnostic check of analog and microprocessor circuitry.
· Low battery indication.
q
7
9 · Calibration reminder timer that alerts the operator, using a calibration icon on the LCD display, to perform a unit calibration.
8
· 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.
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.
It can be used in the hospital and sub-acute settings. The MaxO2 ME is not a
life supporting device.
1.2Essential 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
1.3Component 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.
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 instructions 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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y
g
f
u
d
i
sp ao
y 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.
1.4Max-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 diffuses through the FEP membrane and immediately
reacts electrochemically at a gold cathode. Concurrently, oxidation occurs
electrochemically at a lead anode, generating an electrical current 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
electrolyte, 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 calibration 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.
2.0SETUP PROCEDURE
2.1Battery 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 segments 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 successfully, 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 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 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.
2.2Calibrating the MaxO2 ME Monitor
2.2.1Before 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
calibration 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 pointof-use elevation by more than 500 feet (150m).
In addition, calibration is recommended if the user is unsure when the last
calibration procedure 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.
2.2.2To 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.
2.2.3To 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.
2.2.4Factors Influencing Oxygen Calibration
The primary factors influencing oxygen measurement on the MaxO2 ME monitor are
temperature, 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 temperature changes before reading 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 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 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 ventilator, 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 flowing onto the sensing surface.
3.0OPERATING INSTRUCTIONS
3.1Alarm Setting Procedure
3.1.1Low 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.
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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%.
3.1.2High 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%.
3.1.3Smart 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.
3.2Basic 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.
3.3Alarm 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 level of priority, the monitor provides three unique
audible sequences.
ALARM
ALARM PRIORITY
LOW ALARM LED
HIGH ALARM LED
AUDIBLE ALARM
AUDIBLE ALARM REPEAT
Line Power Plugged In
Informational
Off
Off
2 Pulses No Repeat
Line Power Unplugged
Informational
Single Yellow 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
Off
Pulsing Yellow
3 Pulses Every 25 Sec.
Oxygen level below the low alarm setting
Medium
Pulsing Yellow
Off
3 Pulses Every 25 Sec.
Oxygen level
below the low
oxygen alarm
High Pulsing Red Off
setting and lower
than 18%
5+5 Pulses Every 15 Sec.
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3.4Backlight 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.
3.5Sleep 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.
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 automatically 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.
5.0PROBLEM SOLVING
The MaxO2 ME monitors have a self test feature built into the software to
detect faulty calibrations, 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.
3.6External 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 batteries 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.
4.0SENSOR 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 replacement. 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.
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 concentration 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 monitor 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.
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6.0CLEANING AND MAINTENANCE
6.1Cleaning
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 MaxO2 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.
6.2Alarm 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.
6.3Replacing 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.
7.0SPECIFICATIONS
7.1Base 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
8.0APPLICATIONS
8.1Exposure 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
Nitrous Oxide Halothane Enflurane Isoflurane Helium Sevoflurane Desflurane
VOLUME % DRY
60% balance O2 4% 5% 5% 50%, balance O2 5% 15%
INTERFERENCE IN O2%
<1.5% <1.5% <1.5% <1.5% <1.5% <1.5% <1.5%
NOTE: Balance mixture 30% O2/70%N2O, unless otherwise specified.
8.2Calibration Techniques in Pressurized Systems
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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 monitor. 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 calibrated 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 concentration of oxygen calibration gas and
adjusting the flow and pressure to match the application before calibrating
the instrument.
8.3Calibration Errors
The MaxO2 ME monitor has a self test feature built into the software to detect
faulty calibrations. 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.
9.0SPARE 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 experienced 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)
10.0ELECTROMAGNETIC COMPATIBILITY
The information contained in this section (such as separation distances) is in
general specifically written with regard to the MaxO2 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 information 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 electromagnetic 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 MaxO2 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.
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CISPR Emissions Classification
Class A
Harmonic Emissions Class A (IEC 61000-3-2)
Voltage Fluctuations Complies
The MaxO2 ME is suitable for use in all establishments other than domestic and
those directly connected to the public lowvoltage 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 offer adequate protection to radiofrequency communication
services. The user might need to take mitigation measures, such as relocating
or re-orienting the equipment.
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) ELECTROMAGNETIC
TEST LEVEL
ENVIRONMENT
Professional Healthcare Facility Environment
Home Healthcare Environment
Electrostatic
Contact discharge: ±8 kV
Floors should be wood,
discharge, ESD (IEC 61000-4-2)
Electrical fast transients / bursts (IEC 61000-4-5)
Air discharge: ±2 kV, ±4 kV, ±8 kV, ±15 kV concrete, or ceramic
tile. If floors are covered
Power supply lines: ±2 kV Longer input / output lines: ±1 kV
with synthetic material, the relative humidity should be kept at levels
to reduce electrostatic
Surges on AC mains Common mode: ±2 kV
charge to suitable levels.
lines (IEC 61000-4-5) Diferential mode: ±1 kV
3 A/m power
30 A/m
frequency magnetic 50 Hz or 60 Hz
Mains power quality should be that of a typical commercial or
field 50/60 Hz
hospital environment.
(IEC 61000-4-8)
Voltage dips and Dip>95%, 0.5 periods short interruptions Dip 60%, 5 periods
on AC mains input Dip 30%, 25 periods lines (IEC 61000-4-11) Dip >95%, 5
seconds
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.
Recommended separation distances between portable and mobile RF communications equipment and the equipment
RATED MAXIMUM Separation distance according to frequency OUTPUT POWER of transmitters in meters
OF TRANSMITTER 150 kHz to 80 MHz 80 MHz to 800 MHz
W
d=1.2/V1] P
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
1
1.2
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 affected 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 IEC 60601-1-2: 2014 (4TH ELECTROMAGNETIC ENVIRON-
TEST
EDITION) TEST LEVEL MENT – GUIDANCE
Professional Healthcare Facility Environment
Home Healthcare Environment
Conducted RF coupled into lines (IEC 61000-4-6)
Radiated RF immunity (IEC 61000-4-3)
3V (0.15 – 80 MHz) 6V (ISM bands)
3 V/m
80 MHz – 2.7 GHz 80% @ 1 KHz AM Modulation
3V (0.15 – 80 MHz) 6V (ISM & Amateur bands)
10 V/m
80 MHz – 2.7 GHz 80% @ 1 KHz AM Modulation
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:
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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) telephones 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
measured 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 reorienting or relocating the equipment.
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2305 South 1070 West Salt Lake City, Utah 84119
800-748-5355 www.maxtec.com
References
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