This manual describes the function, operation and maintenance of the Ohio Medical Model MiniOX
200/200E oxygen analyzer. The MiniOX 200/200E Oxygen Analyzer utilizes the Ohio Medical
MiniOX-250 oxygen sensor and is engineered for fast response, maximum reliability and stable
preformance. The MiniOX 200/200E is designed as a tool for use by qualifield personnel to spotcheck or messure oxygen concentration of delivered air/oxygen mixtures. The MiniOX 200/200E
Analyzers are not intended for use in continuous monitoring of oxygen delivery to a patient.
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WARNINGS
!
Indicates a potentially hazardous situation, if not avoided, could result in death or serious injury.
»
Never install the sensor in a location that will expose the sensor to patient’s
exhaled breath or secretions, unless you intend to dispose of the sensor, flow
diverter and tee adapter.
» Improper use of this device can cause inaccurate oxygen readings which can lead to
improper treatment, hypoxia or hyperoxia. Follow the procedures outlined in this user manual.
»
Not for use in an MRI environment.
»
Device specified for dry gas only.
»
Never allow an excess length of tubing, lanyard or sensor cable near the patient’s head or
neck, which may result in strangulation.
»
Before use, all individuals who will be using the MiniOX 200/200E 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.
»
Use only genuine Ohio Medical accessories and replacement parts. Failure to do so may
seriously impair the analyzer’s performance. Repair of this equipment must be performed by a
qualified service technician experienced in repair of portable hand held medical equipment.
»
Calibrate the MiniOX 200/200E weekly when in operation, or if environmental conditions change
significantly. (ie, Elevation, Temperature, Pressure, Humidity — refer to Section 3.0 of this manual).
»
Use of the MiniOX 200/200E near devices that generate electrical fields may cause erratic readings.
»
If the MiniOX 200/200E is ever exposed to liquids (from spills or immersion) or to any other
physical abuse, turn the instrument OFF and then ON. This will allow the unit to go through its
self test to assure everything is operating correctly.
»
Never autoclave, immerse or expose the MiniOX 200/200E (including sensor) to high temperatures
(>70°C). Never expose the device to pressure, irradiation vacuum, steam, or chemicals.
»
This device does not contain automatic barometric pressure compensation.
»
Although the sensor of this device has been tested with various anesthesia gases including nitrous
oxide, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane and found to have acceptably
low interference, the device in entirety (including electronics) is not suitable for use in the presence
of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Only the threaded
sensor face, flow diverter, and “T” adapter may be allowed to contact such a gas mixture.
»
NOT for use with inhalation agents. Operating the device in flammable or explosive atmospheres
may result in fire or explosion.
CAUTION: Indicates a potentially hazardous situation, if not avoided, could result in minor or
moderate injury and property damage.
»
Federal Law (USA) restricts this device to sale by or on the order of a physician.
»
Replace the batteries with recongnized high quality AA Alkaline or Lithium batteries.
DO NOT use rechargeable batteries.
»
If the unit is going to be stored (not in use for 1 month), we recommend that you remove the
batteries to protect the unit from potential battery leakage.
»
The Ohio Medical MiniOX 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 Ohio Medical for proper disposal or recovery.
DO NOT use ethylene oxide sterilization. DO NOT immerse the sensor in any cleaning solution, autoclave or expose the sensor to high
temperatures.
»
Dropping sensor can adversely affect its performance.
»
The device will assume a percent oxygen concentration when calibrating. Be sure to apply
100% oxygen, or ambient air concentration to the device during calibration or the device will not
calibrate correctly.
NOTE: This product is latex free.
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1.0 SYSTEM OVERVIEW
BAT
!
1.1 Base Unit Description
The MiniOX 200/200E analyzer provides unparalleled performance and
reliability due to an advanced design that includes the following features and
operational benefits.
»
Extra-life oxygen sensor of approximately 1,500,000 O2 percent hours (2-year warranty).
»
Durable, compact design that permits comfortable, hand-held operation and easy to clean.
»
Operation using only two AA Alkaline batteries (2 x 1.5 Volts) for
approximately 5000 hours of performance with continuous use. For extra extended
long life, two AA Lithium batteries may be used.
»
Oxygen-specific, galvanic sensor that achieves 90% of final value in
approximately 15 seconds at room temperature.
»
Large, easy-to-read, 3 1/2-digit LCD display for readings in the 0-100% range.
»
Simple operation and easy one-key calibration.
»
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.
1.2 Symbol Guide
The following symbols and safety labels are found on the MiniOX 200/200E:
Follow instructions for use.
Warning
Meets ETL standards
Do not throw away. Follow local
guidelines for disposal.
CAL
Calibration required
Federal Law (USA) restricts this device
only
to sale by or on the order of a physician
Do Not
Contains acid
IPx1
EC REP
On/off Button
Calibration Button
Low Battery
Percent
%
Manufacturer
Serial Number
SN
Lot code/Batch code
LOT
Drip Proof
Catalog Number
REF
Authorized Representative
in the European Community
direct readout of oxygen concentrations in the range of 0 – 105.0%
(100.1% to 105.0% used for calibration determination purposes).
The digits also display error codes and calibration codes as necessary.
Low Battery Indicator - The low battery indicator is located at the top
of the display and is only activated when the voltage on the batteries is
below a normal operating level.
“%” symbol - The “%” sign is located to the right of the concentration
number and is present during normal operation.
Calibration symbol - The calibration symbol is located at the bottom
of the display and is timed to activate when a calibration is necessary.
Keypad
ON/OFF Key - This key is used to turn the device on or off.
Calibration Key - This key is used to calibrate the device. Holding the key
for more than three seconds will force the device to enter a calibration mode.
Sample Inlet Connection - This is the port at which the device is
connected to determine oxygen concentration.
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1.5 MiniOX 250 Oxygen Sensor
®
MiniOX 200
®
AB
FIGURE 2
The MiniOX oxygen sensor offers stability and extra life. The MiniOX 250 is a
galvanic, partial pressure sensor that is specific to oxygen. It consists of two
electrodes (a cathode and an anode), a teflon membrane and an electrolyte.
Oxygen diffuses through the teflon membrane and immediately reacts at a gold
cathode. Concurrently, oxidation occurs electrochemically at the 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 characteristis. 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.
2.0 OPERATING INSTRUCTIONS
2.1 Getting Started
2.1.1 Protect Tape
Prior to turning on the unit, a protective film covering the threaded sensor face
must be removed. After removing the film, wait approximately 20 minutes for
the sensor to reach equilibrium.
2.1.2 Automatic Calibration
After the unit is turned on it will automatically calibrate to room air. The display
should be stable and reading 20.9%.
CAUTION: The device will assume a percent oxygen concentration when calibrating.
Be sure to supply 100% oxygen, or ambient air concentration to the device during
calibration or the device will not calibrate correctly.
To check the oxygen concentration of a sample gas:
(after the unit has been calibrated)
1. Connect the tubing to the bottom of the
analyzer by threading the barbed adapter onto
the oxygen sensor. (FIGURE 2, B)
2. Attach the other end of the sample hose to the
sample gas source and initiate flow of the
sample to the unit at a rate of 1-10 liters per
minute (2 liters per minute is recommended).
3. Using the “ON/OFF” key, make sure the unit
is in the power “ON” mode.
4. Allow the oxygen reading to stabilize. This will
normally take about 30 seconds or more.
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2.2 Calibrating the MiniOX 200/200E Oxygen Analyzer
NOTE: We recommend use of medical grade USP or >99% purity oxygen when
calibrating the MiniOX 200/200E.
The MiniOX 200/200E Analyzer should be calibrated upon initial power-up.
Thereafter, Ohio Medical recommends calibration on a weekly basis. To serve as
a reminder, a one week timer is started with each new calibration. At the end of
one week a reminder icon “
CAL
” will appear on the bottom of the LCD. Calibration
is recommended if the user is unsure when the last calibration procedure was
performed, or if the measurement value is in question. Start calibration by pressing
the key for more than 3 seconds. The MiniOX 200/200E will automatically
detect if you are calibrating with 100% oxygen or 20.9% oxygen (Normal air).
DO NOT attempt to calibrate to any other concentration.
For hospital and home care a new calibration is required when:
» The measured O2 percentage in 100% O2 is below 97.0% O
» The measured O2 percentage in 100% O2 is above 103.0% O
» The CAL reminder Icon is blinking at the bottom of the LCD.
» If you are unsure about the displayed O2 percentage. (See Factors influencing
accurate readings.)
2.
2.
For ID testing, (or optimum accuracy) a new calibration is required when:
» The measured O2 percentage in 100% O2 is below 99.0% O
» The measured O2 percentage in 100% O2 is above 101.0% O
» The CAL reminder Icon is blinking at the bottom of the LCD.
» If you are unsure about the displayed O2 percentage. (See Factors influencing
accurate readings.)
2.
2.
A simple calibration may be made with the sensor open to static ambient
air. For optimum accuracy Ohio Medical recommends that the Sensor be
placed in a closed loop circuit where gas flow is moving across the sensor in a
controlled manner. Calibrate with the same type of circuit and flow that you will
use in taking your readings.
2.2.1 In Line Calibration (Flow Diverter – Tee Adapter)
1. Attach the diverter to the MiniOX 200/200E by threading it on to the bottom
of the analyzer or sensor.
2. Insert the flow diverter into the center position of the tee adapter (FIGURE 2, A).
3. Attach an open-ended reservoir to the end of the tee adapter. Then start the
calibration flow of oxygen at two liters per minute.
» Six to 10 inches of corrugated tubing works well as a reservoir. A calibration oxygen
flow to the MiniOX 200/200E of two liters per minute is recommended to minimize the
possibility of obtaining a “false” calibration value.
4. Allow the oxygen to saturate the sensor. Although a stable value is usually
observed within 30 seconds, allow at least two minutes to ensure that the
sensor is completely saturated with the calibration gas.
5. If the MiniOX 200/200E is not already turned on, do so now by pressing the
analyzer “ON” button.
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6. Press the Cal button on the MiniOX 200/200E until you read the word
CAL on the analyzer display.This can take approximately 3 seconds. The
analyzer will now look for a stable sensor signal and a good reading. When
obtained, the analyzer will display the calibration gas on the LCD.
NOTE: Analyzer will read “Cal Err St” if the sample gas has not stabilized.
2.2.2 Direct Flow Calibration (Barb)
1. Attach the Barbed Adapter to the MiniOX 200/200E by threading it on to the
bottom of the analyzer or sensor.
2. Connect the tube to the barbed adapter. (FIGURE 2, B)
3. Attach the other end of the clear sampling tube to a source of oxygen with
a known oxygen concentration value. Initiate flow of the calibration gas to
the unit. Two liters per minute is recommended.
4. Allow the oxygen to saturate the sensor. Although a stable value is usually
observed within 30 seconds, allow at least two minutes to ensure that the
sensor is completely saturated with the calibration gas.
5. If the MiniOX 200/200E is not already turned on, do so now by pressing the
analyzer “ON” button.
6. Press the Cal button on the MiniOX 200/200E until you read the word
CAL on the analyzer display. This can take approximately 3 seconds.
The analyzer will now look for a stable sensor signal and a good reading.
When obtained, the analyzer will display the calibration gas on the LCD.
3.0 FACTORS INFLUENCING ACCURATE READINGS
3.1 Elevation/Pressure Changes
» Changes in elevation result in a reading error of approximately 1% of reading
per 250 feet.
» In general, calibration of the instrument should be performed when elevation at which
the product is being used changes by more than 500 feet.
» This device does not automatically compensate for changes in barometric pressure
or altitude. If the device is moved to a location of a different altitude, it must be
recalibrated before use.
3.2 Temperature Effects
The MiniOX 200/200E will hold calibration and read correctly within ±3%
when at thermal equilibrium within the operating temperature range. The
device must be thermally stable when calibrated and allowed to thermally
stabilize after experiencing temperature changes before readings are accurate.
For these reasons, the following is recommended:
» For best results, perform the calibration procedure at a temperature close to the
temperature where analysis will occur.
» Allow adequate time for the sensor to equilibrate to a new ambient temperature.
CAUTION: “CAL Err St” may result from a sensor that has not reached thermal equilibrium.
»
When used in a breathing circuit, place the sensor upstream of the heater.
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3.3 Pressure Effects
Readings from the MiniOX 200/200E are proportional to the partial pressure of
oxygen. The partial pressure is equal to the concentration times the absolute
pressure.Thus, the readings are proportional to the concentration if the
pressure is held constant. Therefore, the following are recommended:
»
Calibrate the MiniOX 200/200E at the same pressure as the sample gas.
»
If sample gases flow through tubing, use the same apparatus and flow rates when
calibrating as when measuring.
3.4 Humidity Effects
Humidity (non-condensing) has no effect on the performance of the MiniOX
200/200E other than diluting the gas, as long as there is no condensation.
Depending on the humidity, the gas may be diluted by as much as 4%, which
proportionally reduces the oxygen concentration. The device responds to the
actual oxygen concentration rather than the dry concentration. Environments
where condensation may occur are to be avoided since moisture may obstruct
passage of gas to the sensing surface, resulting in erroneous readings and
slower response time. For this reason, the following is recommended:
» Avoid usage in environments greater than 95% relative humidity.
» When used in a breathing circuit, place the sensor upstream of the humidifier.
HELPFUL HINT: Dry sensor by lightly shaking moisture out, or flow a dry gas at two
liters per minute across the sensor membrane.
4.0 CALIBRATION ERRORS AND ERROR CODES
The MiniOX 200/200E analyzers 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.
E02: No sensor attached
MiniOX 200: Open unit and disconnect and reconnect sensor. Unit should
perform an auto calibration and should read 20.9%. If not, contact Ohio
Medical Customer Service for possible sensor replacement.
MiniOX 200E: Disconnect and reconnect external sensor. Unit should perform
an auto calibration, and should read 20.9%. If not, contact Ohio Medical
Customer Service for possible sensor replacement or cable replacement.
E03: No valid calibration data available
Make sure unit has reached thermal equilibrium. Press and hold the
Calibration Button for three seconds to manually force a new calibration.
E04: Battery below minimum operating voltage
Replace batteries.
CAL Err St: O2 Sensor reading not stable
Wait for displayed oxygen reading to stabilize, when calibrating the device at
100% oxygen.
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Wait for unit to reach thermal equilibrium, (Please note that this can take up
to one half hour, if the device is stored in temperatures outside the specified
operating temperature range).
CAL Err lo: Sensor voltage too low
Press and hold the Calibration Button for three seconds to manually force a
new calibration. If unit repeats this error more than three times, contact Ohio
Medical Customer Service for possible sensor replacement.
CAL Err hi: Sensor voltage too high
Press and hold the Calibration Button for three seconds to manually force a
new calibration. If unit repeats this error more than three times, contact Ohio
Medical Customer Service for possible sensor replacement.
CAL Err Bat: Battery voltage too low to recalibrate
Replace batteries.
5.0 CHANGING THE BATTERIES
Batteries should be changed by service personnel.
» Use only brand name batteries.
» Replace with two AA batteries and insert per orientation marked on the device.
Should the batteries require changing, the device will indicate this in one of two ways:
» The battery icon on the bottom of the display will begin to flash. This icon will
continue to flash until the batteries are changed. The unit will continue to function
normally for approximately 200 hours.
» If the device detects a very low battery level, an error code of “E04” will be present on
the display, and the unit will not function until the batteries are changed.
To change the batteries, begin by removing the three screws from the back of
the device. A #1 Phillips screwdriver is required to remove these screws.
Once the screws are removed, gently separate the two halves of the device.
The batteries can now be replaced from
the back half of the case.
Be sure to orient the new batteries as
indicated in the embossed polarity on the
a back case.
NOTE: If the batteries are installed incorrectly the
batteries will not make contact and the device
will not operate.
Carefully, bring the two halves of the case together
while positioning the wires so they are not pinched
between the two case halves.
The gasket separating the halves will be captured
on the back case half. Reinsert the three screws
and tighten until the screws are snug. (FIGURE 3).
FIGURE 3
7600002 Rev.1
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The device will automatically perform a calibration and begin displaying % of oxygen.
FIGURE 4
LOCK LEVER
HELPFUL HINT: If unit does not function, verify that the screws are tight to allow
proper electrical connection.
HELPFUL HINT (MiniOX 200E): Before closing the two case halves together, verify
that the keyed slot on top of the coiled cable assembly is engaged on the small tab
located on the back case.
This is designed to position the assembly in the correct orientation and prevent
it from rotating. Improper positioning could hinder the case halves from closing
and prevent operation when tightening the screws.
6.0 CHANGING THE OXYGEN SENSOR
6.1 MiniOX 200 Model
Should the oxygen sensor require changing, the device will indicate this by
presenting “Cal Err lo” on the display after initiating a calibration.
To change the oxygen sensor, begin by removing the three screws from the
back of the device.
A #1 phillips screwdriver is required to remove these screws.
Once the screws are removed, gently separate the two halves of the device.
Disconnect the oxygen sensor from the
printed circuit board by pressing the
un-lock lever first and then pulling the
connector out of the receptacle. The
oxygen sensor can now be replaced
from the back half of the case.
HELPFUL HINT: Be sure to orient the new
sensor by aligning the red arrow on the
sensor with the arrow in the back case.
A small tab is located on the back case that is
designed to engage the sensor and prevent it
from rotating within the case. (FIGURE 4)
NOTE: If the oxygen sensor is installed incorrectly, the case will not come back together
and the unit may be damaged when the screws are reinstalled.
NOTE: If the new sensor has red tape over the outside, remove it, then wait 30 minutes
before calibrating.
Reconnect the oxygen sensor to the connector on the printed circuit board.
Carefully bring the two halves of the case together while positioning the wires
to ensure they are not pinched between the two case halves.
Make sure the sensor is fully inserted and in the proper orientation.
Reinsert the three screws and tighten until the screws are snug. Verify the unit
operates properly. The device will automatically perform a calibration and begin
displaying % of oxygen.
8600002 Rev.1
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6.2 MiniOX 200E Model
!
Should the oxygen sensor require changing, the device will indicate this by
presenting “Cal Err lo” on the display.
Unthread the sensor from the cable by rotating the thumbscrew connector
counterclockwise and pull the sensor from the connection. Replace the new
sensor by inserting the electrical plug from the coiled cord into the receptacle
on the oxygen sensor. Rotate the thumbscrew clockwise until snug. The device
will automatically perform a calibration and begin displaying % of oxygen.
7.0 CLEANING AND MAINTENANCE
Store the MiniOX 200/200E analyzer in a temperature similar to its ambient
environment of daily use.
The instruction given below describes the methods to clean and disinfect the
instrument, sensor and its accessories (e.g. flow diverter, tee adapter):
Instrument Cleaning:
» When cleaning or disinfecting the exterior of the MiniOX 200/200E analyzer, take
appropriate care to prevent any solution from entering the instrument.
DO NOT immerse unit in fluids.
» The MiniOX 200/200E analyzer surface may be cleaned using a mild detergent and a
moist cloth.
» The MiniOX 200/200E analyzer is not intended for steam, ethylene oxide or radiation
sterilization.
Oxygen Sensor:
WARNING: Never install the sensor in a location that will expose the sensor
to patient’s exhaled breath or secretions, unless you intend to dispose of the
sensor, flow diverter and tee adapter after use.
» Clean exterior surface of the the sensor with a cloth moistened with isopropyl alcohol
(65% alcohol/water solution).
»
Ohio Medical does not recommend use of spray disinfectants because they can
contain salts, which can accumulate in the sensor membrane and impair readings.
»
The oxygen sensor is not intended for steam, ethylene oxide or radiation sterilization.
Accessories:
»
Sterilizing -The flow diverter and tee adapter. Because of the variability of the
cleaning, disinfecting and sterilizing processes, Ohio Medical cannot provide specific
sterilization instructions, nor can the sterility of the item be ensured.
Ohio Medical recommends that operators carefully examine the flow diverter and tee
adapter after sterilization and prior to use to verify that the item is fit for use. The operator
should verify that there are no cracks and the item does not show any indication of material
changes or physical damage that may compromise its effective use.
Flammable anesthetic mixture: Not suitable for use in presence of a
flammable anesthetic mixture
Product Disposal Instructions:
The sensor, batteries, and circuit board are not suitable for regular trash disposal. Return
sensor to Ohio Medical for proper disposal or dispose according to local guidelines. Follow
local guidelines for disposal of other components.
WARRANTY
The MiniOX 200/200E Analyzer is designed for medical oxygen delivery equipment and systems.
Under normal operating conditions, Ohio Medical warrants the MiniOX 200/200E Analyzer to be
free from defects of workmanship or materials for a period of 2-years from the date of shipment
from Ohio Medical, provided that the unit is properly operated and maintained in accordance with
Ohio Medical’s operating instructions. Based on Ohio Medical product evaluation, Ohio Medical’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 Ohio Medical or through Ohio Medical 's designated distributors and
agents as new equipment.
Ohio Medical warrants MiniOX oxygen sensors in the MiniOX 200/200E Analyzers to be free from
defects in material and workmanship for a period of 2-years from Ohio Medical’s date of shipment
in a MiniOX 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. Ohio Medical 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.
Manufactured By:
Maxtec, LLC
2305 South 1070 West
Salt Lake City, UT 84119
U.S.A.
Authorized Representative:
EC REP
QNET BV
Kantstraat 19
NL-5076 NP Haaren
The Netherlands
12600002 Rev.1
Distributed By:
Ohio Medical, LLC
1111 Lakeside Drive
Gurnee, IL 60031
TEL 866.549.6446
www.ohiomedical.com
U.S.A.