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®
MiniOX
MiniOX
OPERATING MANUAL &
INSTRUCTIONS FOR USE
®
100
CAL
®
®
100
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TABLE OF CONTENTS
WARNINGS, CAUTION
1.0 INTRODUCTION.............................................1
1.1 Component Identification .........................................1
1.2 Symbol Guide ..................................................2
1.3 Description ....................................................2
2.0 CALIBRATING THE MINIOX 100 .................................2
2.1 Before you begin................................................2
2.2 Calibrating the MiniOX 100 Oxygen Analyzer ...........................3
2.3 In-Line Calibration (Configuration A) .................................3
2.4 Direct Flow Calibration (Configuration B) ..............................4
3.0 OPERATING THE MINIOX 100 ..................................4
4.0 FACTORS INFLUENCING ACCURATE READINGS .....................5
4.1 Elevation Changes...............................................5
4.2 Temperature Effects .............................................5
4.3 Pressure Effect .................................................5
4.4 Humidity Effect.................................................6
5.0 CALIBRATION ERRORS AND ERROR CODES ........................6
6.0 CLEANING AND MAINTENANCE .................................7
7.0 SPECIFICATIONS............................................7
7.1 Analyzer Specifications ...........................................7
7.2 Effect of Interferent Gases and Vapors................................8
8.0 MINIOX 100 SPARE PARTS AND ACCESSORIES .....................8
8.1 Standard Replacement Parts and Accessories..........................8
9.0 FREQUENTLY ASKED QUESTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
CLASSIFICATION, WARRANTY ....................................10
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WARNINGS
!
Indicates a potentially hazardous situation, if not avoided, could result in death
or serious injury.
»
Before use, all individuals who will be using this product must become thoroughly
familiar with the information contained in this Operation Manual. Strict
adherence to the operating instructions is necessary for safe and effective product
performance. This product will perform only as designed and only if installed and
operated in accordance with the manufacturer's operating instructions.
»
Although the sensor of this device has been tested with various anesthetic 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.
»
This device does not contain automatic barometric pressure compensation.
DO NOT use near any type of flame or flammable/explosive substances, vapors
or atmosphere.
»
Not for use in an MRI environment.
» 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.
CAUTION: Indicates a potentially hazardous situation, if not avoided, could result in
minor or moderate injury and property damage.
» The Ohio Medical MiniOX-250 oxygen sensor is a sealed device containing a weak 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.
» The MiniOX 100 is not intended for steam, ethylene oxide or radiation sterilization.
DO NOT autoclave or expose the sensor to high temperatures.
DO NOT immerse the MiniOX 100 oxygen analyzer in any cleaning solution.
» The flow diverter provided with the MiniOX 100 is for use with flowing gases only.
DO NOT use the diverter when performing static sampling (e.g., in incubators,
oxygen tents, oxygen hoods).
DO NOT attempt any repairs or procedures, which are not described in this
Operation Manual. Ohio Medical cannot warrant this product from damage resulting
from misuse, unauthorized repair or improper maintenance of this product.
» The Federal (USA) law restricts this device to sale by or on the order of a physician.
» There are no internal user-serviceable parts.
» Never install the sensor in a location that will expose the sensor to patient’s exhaled
breath or secretions.
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1.0 INTRODUCTION
1.1 Component Identification
TOP VIEW
LCD DISPLAY
"ON" BUTTON
CALIBRATION BUTTON
LCD Display: A 3-digit display provides a direct readout of oxygen
concentration in the range of 0 - 100%. The display is blank when the MiniOX
100 enters its Sleep (power off) mode. The MiniOX 100 will automatically enter
the Sleep mode after approximately 1.3 minutes from the last time the ON
button was pressed.
ON/OFF Button: Use this button to turn the MiniOX 100 on and off. When the
MiniOX 100 is in the Sleep (power off) mode, the LCD display is blank.
The analyzer turns off after 1.3 minutes if no buttons are pressed.
Calibration Button: Press the calibration (CAL) button to adjust the calibration
value to reflect the known oxygen concentration. To simplify operation, the
MiniOX 100 Analyzer automatically determines the calibration gas being used
as room air (20.9%) or high grade (100%).
Flow Diverter: The flow diverter is designed to fit industry standard 15 mm
I.D. "T" adapters.
Over Range Indicator: The appearance of a decimal point after the first digit
means that the MiniOX 100 is reading in excess of 99.9%.
Example: .......................................0.0.0 = 100%
..............................................0.0.1 = 101%
..............................................0.0.2 = 102%
....(If the display reads > 0.0.3 the MiniOX 100 should be re-calibrated.)
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1.2 Symbol Guide
!
The following symbols and safety labels are found on the the MiniOX 100:
Do not throw away. Follow local
guidelines for disposal.
Contains acid
Federal law (USA) restricts this device
only
to sale by or on the order of a physician.
Meets ETL standards
Warnings
Do Not
Manufacturer
IPX1
EC REP
On/off Button
Calibration Button
Follow instructions for use
Serial Number
SN
Catalog Number
REF
Lot code/Batch code
LOT
Drip Proof
Authorized Representative
in the European Community
1.3 Description
The Ohio Medical MiniOX 100 oxygen analyzer is designed to monitor
oxygen concentration in the patient-breathing environment. It is one of a full
line of oxygen analyzers by Ohio Medical. The MiniOX 100 oxygen analyzer
utilizes the MiniOX 250 oxygen sensor and is engineered for fast response,
maximum reliability and stable performance. The MiniOX 100 is designed
primarily for spot-checking of oxygen levels delivered by medical oxygen
delivery equipment and respiratory care systems. Its lightweight, compact size,
extended battery life, and "auto off" feature makes this oxygen analyzer ideal
for portable oxygen analysis by qualified heath care professionals.
2.0 CALIBRATING THE MINIOX 100
2.1 Before You Begin
A protective film covering the threaded sensor face must be removed and
the sensor allowed to “breath” for at least 30 minutes. Next, the MiniOX 100
Oxygen Analyzer should be calibrated. Thereafter, Ohio Medical recommends
calibration on a weekly basis. However, more frequent calibration will not
adversely affect product performance.
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2.2 Calibrating the MiniOX 100 Oxygen Analyzer
Calibration of the instrument is necessary if the temperature of the gas stream
changes by more than 3 degrees Celsius.
Changes in elevation result in calibration error of approximately 1% of reading
per 250 feet. In general, calibration of the instrument should be performed
when the geographic elevation at which the product is being used changes by
more than 500 feet.
In addition, calibration is recommended if the user is unclear when the last calibration
procedure was performed or if the measurement value displayed is in question.
Calibrate the MiniOX 100 to an oxygen source, which has a traceable
certificate and/or USP certification, of either 20.9% oxygen, as found in
room air, or 100% oxygen. It is recommended that the oxygen source be
documented at a pressure and flow similar to your clinical application.
Note: Before beginning calibration the MiniOX 100 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" on
page 5 of this manual.
Note: We recommend use of medical grade USP or >99% purity oxygen when
calibrating the MiniOX 100.
2.3 In Line Calibration (Configuration A)
1. Put the MiniOX 100 in an upright position such that you can read the product label.
2. Connect a sample supply hose to a standard "T" piece. The Ohio Medical "T" is
precision-tapered to insure a tight connection with O-rings of the flow diverter.
3. Insert the MiniOX 100 in the center position of the "T" piece.
4. Attach an open-ended reservoir to the end of the "T" piece. Then start the
calibration flow of oxygen at 1-10 liters per minute.
Note: Six to 10 inches of corrugated tubing works well as a reservoir.
Note: A calibration oxygen flow to the MiniOX 100 of 2 liters per minute is recommended
to minimize the possibility of obtaining a "false" calibration value.
5. Allow the oxygen to saturate the sensor. Although a stable value is usually
observed within 30 seconds, allow at least 2 minutes to ensure that the
sensor is completely saturated with the calibration gas.
6. If the MiniOX 100 is not already turned on, do so now by pressing the
analyzer ON button .
7. Press the “CAL” button on the MiniOX 100. The calibration gas value on the
analyzer display should read 20.9 or 100 depending on the gas stream used.
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2.4 Direct Flow Calibration (Configuration B)
1. Attach the Barbed Adapter to the MiniOX 100.
2. Connect the clear sampling tube to the Barbed Adapter.
3. Attach the other end of the clear sampling tube to a source of oxygen with a
known oxygen concentration value and initiate flow of the calibration gas to the
unit at a rate of 1-10 liters per minute (2 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 2 minutes to ensure complete
saturation of the sensor with the calibration gas.
5. If the MiniOX 100 is not already turned on, do so now by pressing the
analyzer “ON” button .
6. Press the “CAL” button on the MiniOX 100. The calibration gas value on the
analyzer display should read 20.9 or 100 depending on the gas stream used.
Configuration A
Flow Diverter
Configuration B
Barbed
Adapter
"T" Adaptor
Clear
Tubing
(To gas)
3.0 OPERATING THE MINIOX 100
To Check the Oxygen Concentration of a Sample Gas:
1. Maintain the MiniOX 100 in an upright position such that you can read the
product label.
2. Place the MiniOX 100 in the sample gas stream.
IMPORTANT:
» When using a standard "T" adapter, make sure that the sensor is mounted in the
adapter with the flow diverter pointing down.
» Make sure that there is a tight fit between the flow diverter and the "T" adapter.
3. Start the flow of the sample gas to the sensor.
4. Allow the oxygen sensor to remain in the flow of the sample gas until stable.
5. If the MiniOX 100 is not already turned on, do so now by pressing the
analyzer ON button .
6. Read the value displayed on the LCD.
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NOTE: If the MiniOX 100 is used to measure the oxygen concentration with equipment
using a heated or humidified gas stream, it is recommended that the MiniOX 100 be
placed upstream of the heater and/or humidifier. For more information, refer to "Factors
Influencing Calibration and Performance" on page 5 of this manual.
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% O2.
2
For ID testing (or optimum accuracy), a new calibration is required when:
» The measured O2 percentage in 100% O2 is below 99.0% O2.
» The measured O2 percentage in 100% O2 is above 101.0% O2.
4.0 FACTORS INFLUENCING ACCURATE READINGS
4.1 Elevation Changes
» Changes in elevation result in a reading error of approximately 1% of reading per 250 feet.
» A change in altitude greater than 500 ft will require sensor recalibration.
» 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 (see section 2.2).
4.2 Temperature Effects
The MiniOX 100 will hold calibration and read correctly within ±3% when in
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:
» When used in a breathing circuit, place the sensor upstream of the heater.
» 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.
4.3 Pressure Effect
Readings from the MiniOX 100 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. 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:
» Calibrate the MiniOX 100 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.
» The MiniOX 100 oxygen sensor has been validated at pressures up to 2 atmospheres
absolute. Calibration or operation above this pressure is beyond the intended use.
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4.4 Humidity Effect
Humidity has no effect on the performance of the MiniOX 100 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 condensate 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.
5.0 CALIBRATION ERRORS AND ERROR CODES
The MiniOX 100 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.
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
Unit is at end of life, see page I for proper disposal.
CAL Err St: O2 Sensor reading not stable
Wait for displayed oxygen reading to stabilize when calibrating the device at
100% oxygen. 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 product 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 product replacement.
CAL Err Bat: Battery voltage too low to recalibrate
Unit is at end of life, see page I for proper disposal.
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6.0 CLEANING AND MAINTENANCE
When cleaning or disinfecting the MiniOX 100, take appropriate care to prevent
any solution from entering the analyzer.
» The MiniOX 100 surface may be cleaned using a cloth moistened with 65% isopropyl
alcohol/water solution or germicidal wipe.
» The MiniOX 100 may be disinfected using standard topical disinfectants.
» The MiniOX 100 is not intended for steam, ethylene oxide or radiation sterilization.
» Store the MiniOX 100 in a temperature similar to its ambient environment of daily use.
7.0 SPECIFICATIONS
7.1 Analyzer Specifications
Measurement Range: ...............................0.0 - 99.9% oxygen (gas)
Resolution/Display:................................................0.1%
The three digit LCD indicates values between 0.0 - 99.9% oxygen
Over range indicated by one decimal point on display located after the first digit
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 temp range
Response Time: ....................< 15 seconds for 90% step change. (at 25˚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)
Environmental: ..................General purpose housing equivalent to NEMA 1.
The MiniOX 100 is not waterproof.
Warranty: .........................Two (2) years in normal operating conditions
Power Requirements: ...............................Powered by one internal,
non-replaceable Lithium battery, CR2450.
Power on push button automatically shuts off after 80 seconds time-out.
Electronics rated general purpose;
not for use in hazardous areas or for use with flammable gases.
Sensor Type: .....................Ohio Medical MiniOX Series galvanic fuel cell
Weight:............................................... Approx. 60 grams
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7.2 Effect of Interferent Gases and Vapors
2.45 in
1.44 in
2.91 in
0.90 in
Gas Volume % Dry Interference in O
Nitrous Oxide 75% < 2%
Halothane 5% < 2%
Isoflurance 5% < 2%
Enflurane 5% < 2%
Sevoflurane 6% < 2%
Desflurane 15% < 2%
Carbon Dioxide 10% < 2%
Helium 70% < 2%
8.0 MINIOX 100 SPARE PARTS AND ACCESSORIES
8.1 Standard Replacement Parts and Accessories
Part Number Item
606901 "T" Adapter
606902 Flow Diverter
606903 Barbed Adapter w/ Tubing
606904 Lanyard
2
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9.0 Frequently Asked Questions
After I calibrate to 20.9%, the display changes as much as ± 1%.
» This is within the normal MiniOX 100 operating tolerance of ± 1% when temperature
and pressure are constant.
I have calibrated to 99.9% but when I check my oxygen delivery equipment,
the MiniOX 100 reads ".0.4" or greater (Over Range Indicator).
» It is recommended that you conduct the calibration procedure again to get another
reading. The most likely cause is that the MiniOX 100 has received a "false" calibration value.
» Make sure that the calibration gas is connected to the MiniOX 100 at 2 liters per minute
for a minimum of 2 minutes prior to proceeding with calibration.
» This 2-minute equilibration time is necessary to insure that the sensor is completely
saturated with the calibration gas.
I have found the reading to drift greater than ± 3% from a know source
value. What is the possible cause?
» The sensor may be at or near its useful life.
» Replace your MiniOX 100.
» Sensor life is dependent on the oxygen concentration exposure.
For example, a sensor which is used to check flow meters once a week for 8
hours will outlast one which is used to analyze oxygen blender performance
24 hours per day, 5 days a week.
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CLASSIFICATION
Classification:...............................................Class II medical device.
Protection against electric shock: ..........................Internally powered equipment.
Protection against water: ....................................................IPX1
Mode of Operation: ...................................................Continuous
Sterilization: ......................................................See section 6.0
Flammable anaesthetic mixture:.......................Not suitable for use in presence of a
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
Ohio Medical, warrants the MiniOX 100 to be free from defects of
workmanship or materials for a period of two-(2) years from the date of
shipment from Ohio Medical, under normal operating conditions and provided
that the MiniOX 100 is properly operated and maintained in accordance with
Ohio Medical's operating instructions. Should MiniOX 100 fail prematurely,
the replacement MiniOX 100 is warranted for the remainder of the original
analyzer warranty period. Based on Ohio Medical's 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/or
agents as new equipment. Routine maintenance items are excluded from this
warranty. Ohio Medical shall not be liable to the purchaser or other persons for
incidental or consequential damages or equipment that has been subject to
abuse, misuse, misapplication, 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.
flammable anaesthetic mixture
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
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Distributed By:
Ohio Medical, LLC
1111 Lakeside Drive
Gurnee, IL 60031
TEL 866.549.6446
www.ohiomedical.com
U.S.A.
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®
© 2017 Ohio Medical, LLC.
This document contains information that is proprietary and confidential to Ohio Medical, LLC.
Use of this information is under license from Ohio Medical, LLC.
Any use other than that authorized by Ohio Medical, LLC is prohibited.
MiniOX, Ohio Medical and the Ohio Medical logo are registered trademarks of Ohio Medical, LLC.
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